BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 6140279 · Received December 1, 2016

    Report

    Report Number
    2950679-2016-00006
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 2, 2016
    Report Date
    December 1, 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 A FAILURE OF TWO SET SCREWS LED TO A MECHANICAL FAILURE OF THE STANDARD TREATMENT COUCH TABLE TOP. THIS UNEXPECTED COUCH TABLE TOP DESCENT OCCURRED WHILE THE OPERATOR WAS REMOVING A PATIENT FROM THE COUCH. IT WAS DETERMINED THAT THE TWO SET SCREWS WERE LOOSE, HAVING PRESUMABLY BACKED OUT. THE SET SCREWS HOLD THE TREATMENT COUCH TABLE TOP ROLL AXIS PIVOT PIN IN PLACE, WITH EACH END IN A PIVOT MOUNTING BLOCK. WHEN THE SET SCREWS BACKED OUT, THE ROLL AXIS PIVOT PIN SLID PARTIALLY OUT OF ONE OF THE MOUNTING BLOCKS, REMOVING PARTIAL SUPPORT TO THE TREATMENT COUCH TABLE TOP, LEADING TO THE UNEXPECTED DESCENT. THERE WAS NO OPERATOR OR PATIENT INJURY. HOWEVER, GIVEN THE POTENTIAL FOR INJURY 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 THE STANDARD TREATMENT COUCH EXPERIENCED AN UNEXPECTED DESCENT DUE TO A SET SCREW TORQUE ISSUE WHILE A PATIENT WAS BEING REMOVED. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790888 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY INCORPORATED G4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1