BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECLIPSE

    MDR report key: 713423 · Received May 12, 2006

    Report

    Report Number
    3003793371-2006-00002
    Event Type
    Other
    Date Received
    May 12, 2006
    Date of Event
    February 28, 2006
    Report Date
    February 28, 2006
    Manufacturer
    VARIAN MEDICAL SYSTEMS, FINLAND OY
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CANCER SPECIALIST CONTACT CREATED DIGITALLY RECONSTRUCTED RADIOGRAPHS (DRR'S) WITH AN ISOCENTER NOT MATCHING THAT OF AN INTENSITY MODULATED RADIATION THERAPY (IMRT) PLAN. DRR'S WERE USED TO SET UP AND TREAT THE PATIENT FOR THREE FRACTIONS. CONTACT CALLED VARIAN FOR GUIDANCE ON USING ECLIPSE TO ANALYZE THE DOES THAT WAS DELIVERED TO THE PATIENT. PER FOLLOW-UP CONVERSATION ON 3/13/06, CONTACT DETERMINED THAT NO SERIOUS INJURY HAD OCCURRED. CONTACT ALSO CONCLUDED THAT HTE INCIDENT WAS DUE TO USE ERROR AND DID NOT INVOLVE EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS, FINLAND OY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other