BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 2103697 · Received May 13, 2011

    Report

    Report Number
    2950679-2011-00002
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ACCURAY, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT TREATED FOR A MID-PARENCHYMAL LEFT LOWER LOBE MASS EXPERIENCED A COLLAPSE OF THE LEFT LOWER LOBE EIGHT MONTHS AFTER TREATMENT. THIS EVENT IS CONSIDERED A KNOWN RISK OF TREATING SUCH A TUMOR IN THIS LOCATION AND IS NOT ATTRIBUTED TO MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PT HAS DEMONSTRATED FAVORABLE RESPONSE TO TREATMENT WITH MARKED REGRESSION IN TUMOR SIZE AND IMPROVED CONTROL OF DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY, INC. CYBERKNIFE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention