BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN / ZMED STEREOTACTIC RADIOSURGERY

    MDR report key: 1823547 · Received August 28, 2010

    Report

    Report Number
    MW5017285
    Event Type
    Injury
    Date Received
    August 28, 2010
    Report Date
    August 28, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN STEREOTACTIC RADIOSURGERY PATIENT AT (B)(6) RADIATION ONCOLOGY IN (B)(6) WAS GIVEN TREATMENT WITHOUT THE FICONFL DEVICE THAT LIMITS THE RADIATION BEAM TO A RELATIVELY SMALL -APPROXIMATELY 14 TO 20MM- CIRCULAR BEAM. THE PATIENT RECEIVED A PORTION OF HER TREATMENT WITH A 5CM BY 5CM SQUARE BEAM BEFORE THE ERROR WAS RECOGNIZED AND THE TREATMENT STOPPED. THE MEDICAL DEVICE USED FOR THE STEREOTACTIC RADIOSURGERY TREATMENT WAS SOLD BY VARIAN. THE DEVICE WAS ORIGINALLY DEVELOPED BY (B)(4), A COMPANY THAT VARIAN NOW OWNS. THE DEVICE LACKS A SAFETY INTERLOCK WHICH WOULD PREVENT TREATMENT WITHOUT THE CIRCULAR BEAM LIMITING CONE BEING IN PLACE. THIS IS A GLARING DEFICIENCY IN THE PRODUCT DESIGN. VARIAN LINEAR ACCELERATORS HAVE MANY INTERLOCK SAFETY SYSTEMS. IT'S VERY ODD, AND IN MY OPINION IRRESPONSIBLE, THAT VARIAN WOULD MARKET A SYSTEM WITHOUT A BASIC, SIMPLE SAFETY INTERLOCK WHEN THAT SYSTEM IS DESIGNED TO GIVE A VERY HIGH RADIATION DOSE IN ONE TREATMENT. THIS ERROR OCCURRED SEVERAL YEARS AGO. (B)(6) RADIATION ONCOLOGY HAS NOT TREATED VERY MANY STEREOTACTIC PATIENTS, SO THE PATIENT'S NAME SHOULD BE RELATIVELY EASY TO FIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN / ZMED STEREOTACTIC RADIOSURGERY VARIAN / ZMED STEREOTACTIC RADIOSURGERY MUJ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1