BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 3790374 · Received April 21, 2014

    Report

    Report Number
    2950679-2014-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ACCURAY, INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K122137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROBOT HAD HIT THE CEILING WHILE GOING TO PICK UP THE COLLIMATOR DURING A TREATMENT. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241014 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY, INCORPORATED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1