BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 1422007 · Received March 23, 2009

    Report

    Report Number
    2950679-2009-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 23, 2009
    Manufacturer
    ACCURAY, INCORPORATED
    Product Code
    MUJ
    PMA / PMN Number
    K011024
    Removal / Correction Number
    2950679-3/23/09-005C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURAY FIELD SERVICE ENGINEERING INVESTIGATED THE EVENT AT THE FACILITY AND CONFIRMED THAT THE EXTENSION COUPLER HAD BECOME LOOSE CAUSING THE BOOM ARM ASSEMBLY TO UNEXPECTEDLY DESCEND. THE EVENT HAS BEEN TRACED TO A SLOW ROTARY CREEP OF THE COUPLING AS THE MOUNTING SYSTEM IS MANIPULATED IN DAILY USE. ONE OF THE VERTICAL AXES OF ROTATION IS DIRECTLY LINED UP WITH THE CENTER OF ROTATION FOR THE THREAD OF THE COUPLING. OVER TIME WITH THE ROTATION OF THE AXES THERE WILL BE SMALL AMOUNTS OF TORQUE ON THE COUPLING TO EXTENSION JOINT. THIS WILL ALLOW THE CONNECTION TO SLOWLY WORK LOOSE. ALL AFFECTED SITES WERE NOTIFIED OF THE POTENTIAL PROBLEM VIA CUSTOMER ADVISORY NOTIFICATION.

    Description of Event or Problem · 1

    THE BOOM ARM ASSEMBLY OF THE SYNCHRONY RESPIRATORY TRACKING SYSTEM UNEXPECTEDLY DESCENDED CONTACTING THE RADIATION TECHNICIAN. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM MUJ ACCURAY, INCORPORATED CYBERKNIFE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention