BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 6122171 · Received November 22, 2016

    Report

    Report Number
    2950679-2016-00003
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K122137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURAY INCORPORATED EVALUATED THE DEVICE IN QUESTION AND DETERMINED THAT IF A CERTAIN SEQUENCE OF EVENTS WERE FOLLOWED, THERE COULD BE A ROBOT MOVEMENT AT AN UNEXPECTED TIME. THIS UNEXPECTED MOVEMENT COULD OCCUR WHILE THE OPERATOR WAS IN THE PROCESS OF REMOVING AN ACCESSORY. THERE WAS NO OPERATOR OR PATIENT CONTACT OR INJURY. ADDITIONALLY, GIVEN THE STEPS NECESSARY A PATIENT WOULD NOT BE PRESENT DURING THIS ACTIVITY AND THE MOVEMENT IS SUCH THAT AN OPERATOR WOULD BE EXPECTED TO MOVE OUT OF THE WAY AND NOT BE INJURED. HOWEVER, GIVEN THE POTENTIAL INJURY OR DAMAGE IF AN ACCESSORY CONTACTED THE EXCHANGE TABLE THIS IS BEING REPORTED AND A CORRECTION FOR THIS IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM WHERE UNEXPECTED ROBOT MOVEMENT MAY OCCUR WHILE REMOVING A COLLIMATOR ACCESSORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771255 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY INCORPORATED M6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1