BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 3012522 · Received March 15, 2013

    Report

    Report Number
    2950679-2013-00004
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ACCURAY, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT ENROLLED IN A NON ACCURACY SPONSORED STUDY, UNDER (B)(4) OVERSIGHT, EXPERIENCED COMPLICATIONS. THE PT EXPERIENCED PELVIC PAIN AND PROSTATE SLOUGHING AND UNDERWENT A CYSTOPROSTATECTOMY. THE PHYSICIAN INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE. DUE TO THE NATURE OF THE FOLLOW UP INTERVENTION, AND THE LACK OF RELATED DETAILS, THIS IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110838 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other