BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 3853142 · Received May 22, 2014

    Report

    Report Number
    2950679-2014-00002
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    July 23, 2013
    Report Date
    April 11, 2014
    Manufacturer
    ACCURAY, INC
    Product Code
    IYE
    PMA / PMN Number
    K122137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOTHERAPY TREATMENT FOR PROSTATE CANCER HAS AN APPROXIMATE FIVE PERCENT RISK OF CONTRIBUTING TO SUBSEQUENT BLADDER CANCER. WHILE IT IS NOT POSSIBLE TO MAKE A DEFINITIVE DETERMINATION AS TO THE ROOT CAUSE OF THE BLADDER CANCER, THE PRIOR PROSTATE RADIOSURGERY TREATMENT CANNOT BE RULED OUT. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL RESEARCH SITE REPORTED THAT STUDY PT (B)(6) RECEIVED CYBERKNIFE TREATMENT FOR PROSTATE CANCER ON (B)(6) 2009. IN (B)(6) 2013, THE PT WAS DIAGNOSED WITH A GRADE 3 PAPILLARY BLADDER TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306826 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening