BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE DESKTOP

    MDR report key: 494038 · Received November 7, 2003

    Report

    Report Number
    9617016-2003-00019
    Event Type
    Injury
    Date Received
    November 7, 2003
    Date of Event
    October 13, 2003
    Report Date
    October 30, 2003
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED A PATIENT RECEIVED 22 OUT OF 24 FRACTIONS WITH MLC LEAVES IN AN INCORRECT POSITION. THE CUSTOMER BELIEVED IT WAS NOT POSSIBLE TO TREAT A FIELD WHEN THE LEAVES ARE BEHIND THE BACKUP COLLIMATOR. THE PATIENT HAS RECEIVED APPROXIMATELY 10% ADDITIONAL RADIATION TO AN AREA 17X16.4CM. THE PHYSICIAN ADVISED THAT THE PATIENT RECEIVED 250CGY TO THE UNINTENTIONAL VOLUME THAT INCLUDED THE UNRELATED BREAST AND HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE DESKTOP MEDICAL LINEAR ACCELERATOR CONTROL SYSTEM IYE ELEKTA LIMITED RT DESKTOP, R4.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other