BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING & TANDEM APPLICATOR - CT & MR COMPATIBLE

    MDR report key: 1013984 · Received March 12, 2008

    Report

    Report Number
    8020711-2008-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Report Date
    March 11, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K030110
    Removal / Correction Number
    8020711-3/6/08-0001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ENGINEERING INVESTIGATION HAS DETERMINED THE SOURCE WIRE LOCATION IN THE RING OF THE RING & TANDEM APPLICATOR SET MAY NOT BE POSITIONED AS INTENDED ACCORDING TO THE DOSE DELIVERY PLAN. DUE TO A SNAKING EFFECT OF THE SOURCE WIRE IN THE ROUND RING, THE PLANNED DWELL POSITIONS MAY BE OFF BY MORE THAN 2MM. IN ACCORDANCE WITH MEDICAL ELECTRICAL EQUIPMENT STANDARD REQUIREMENTS, THE POSITION OF THE SOURCE WITHIN THE SOURCE APPLICATOR MAY BE GREATER THAN 2MM, AND THEREFORE INFORMATION WILL BE SUPPLIED IN THE ACCOMPANYING DOCUMENTATION FOR THE USER. THERE HAVE BEEN NO REPORTS OF INJURY RELATED TO THIS ISSUE TO DATE. INVESTIGATION HAS DETERMINED IN A WORSE CASE SCENARIO THE POSITIONING DIFFERENCE COULD LEAD TO A MARGINAL PATIENT RISK WHICH COULD RESULT IN MINOR INJURY OR ILLNESS RESULTING IN NEED FOR ROUTINE, NON-EMERGENCY MEDICAL ATTENTION. THE POSITIONING OF THE SOURCE WIRE COULD LEAD TO A HIGHER THAN PLANNED DOSE TO SURROUNDING CRITICAL STRUCTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RING & TANDEM APPLICATOR - CT & MR COMPATIBLE BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS AL13017000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other