BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVIX APPLICATOR SET WITH CT-CYLINDERS

    MDR report key: 2111097 · Received May 20, 2011

    Report

    Report Number
    9612638-2011-00003
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS HAAN GMBH
    Product Code
    JAQ
    PMA / PMN Number
    K033371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPLICATOR PROBE HAS BEEN SENT TO (B)(4) FOR INVESTIGATION AND ANALYSIS. A REPLACEMENT WAS ORDERED FOR THE CUSTOMER. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A WELD BROKE ON THE TANDEM. THE BROKEN WELD WAS DISCOVERED AFTER A TREATMENT AND THE TANDEM WAS DISCONTINUED CLINICALLY AND VARIAN NOTIFIED. THE WELD (ADHESIVE BOND) WAS REPORTED TO BE BROKEN AT THE TREATMENT END OF THE TANDEM DEVICE, AT THE DIAMETER SIZE TRANSITION. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVIX APPLICATOR SET WITH CT-CYLINDERS SYSTEM, APPLICATOR, RADIONUCLIDE, R-C JAQ VARIAN MEDICAL SYSTEMS HAAN GMBH G22

    Patients

    Seq Age Sex Outcome Treatment
    1