BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMAMED PLUS HDR AFTERLOADING SYSTEM

    MDR report key: 2240875 · Received August 8, 2011

    Report

    Report Number
    9612638-2011-00006
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS HAAN GMBH
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGATION HAS BEEN CONFIRMED: THE TANDEM GM BROKE AS IT WAS INSERTED INTO THE PT. VARIAN INVESTIGATION HAS DETERMINED THAT THIS ISSUE IS THE RESULT OF A FAULTY WELD/ WELDING PROCESS. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED AND REPORTED. VARIAN MODIFIED ITS WELDING PROCESS FOR INTRAUTERINE PROBES. A CAPA HAS BEEN ISSUED AND FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADD'L FOLLOW UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT THE TANDEM (B)(4) BROKE AT THE STOPPER AS IT WAS INSERTED INTO THE PT. THE CUSTOMER SWITCHED TO A DIFFERENT PROBE AND PT WAS TREATED SUCCESSFULLY. NO UNUSUAL FORCE WAS USED PER THE PHYSICIAN. NO PT INJURY OR TREATMENT MISADMINISTRATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAMED PLUS HDR AFTERLOADING SYSTEM SYSTEM, APPLICATOR, RADIONUCLIDE, R-C MUJ VARIAN MEDICAL SYSTEMS HAAN GMBH H64

    Patients

    Seq Age Sex Outcome Treatment
    1