BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMAMED

    MDR report key: 1375193 · Received February 18, 2009

    Report

    Report Number
    9612638-2009-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    January 20, 2009
    Report Date
    February 18, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K983436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED. BY SUBMITTING THIS REPORT, THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED HAS MALFUNCTIONS, IS DEFECTIVE, OR HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE.

    Description of Event or Problem · 1

    VARIAN IDENTIFIER: GM 016/2009. ERROR DESCRIPTION: IN PREPARATION TO USE THE AFTERLOADING DEVICE GAMMAMED PLUS THE USER IS ADVISED TO PERFORM A DAILY QA TEST PRIOR TO USE THE DEVICE. WHILE PERFORMING THEIR MORNING QA TEST WITH THE GAMMAMED PLUS THE SOURCE WIRE WAS EXTENDED FOR TESTING AND GOT STUCK OUTSIDE THE AFTERLOADING DEVICE. PERFORMING EMERGENCY PROCEDURE INCLUDING ENTERING THE TREATMENT ROOM AND ATTEMPTED MANUAL RETRACTION BY THE PHYSICIST DID NOT SUCCEED IN RETRACTING THE SOURCE WIRE. A MANUAL RECOVERY OF THE SOURCE WIRE WAS NECESSARY AND PERFORMED BY THE FIELD SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAMED BRACHYTHERAPY SYST. REMOTE AFTERLOADING JAQ VARIAN MEDICAL SYSTEMS PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other