BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XKNIFE RT LINUX WORKSTATION

    MDR report key: 1711126 · Received May 20, 2010

    Report

    Report Number
    1222895-2010-00004
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Report Date
    May 20, 2010
    Manufacturer
    INTEGRA RADIONICS
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO. INTEGRA ENGINEERS COMPLETED A PRELIMINARY EVAL OF THIS DEVICE AND THE FOLLOWING WAS DETERMINED; THE PRELIMINARY INVESTIGATION DETERMINED THAT THE "DIAMETER" PARAMETER FOR THE 30.0 MM CONE IN THE SITES' BEAM DATA FILE HAD BEEN INCORRECTLY SET TO 37.5 MM. OTHER PARAMETERS FOR THE 30.0 MM CONE WERE FOUND TO BE CORRECT. ADDITIONAL INFO HAS BEEN REQUESTED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    XKNIFE RT LINUX WORKSTATION; THE OUTLINE OF THE 3 CM CONE IN THE SOFTWARE APPEARED BIGGER THAN THE 3.5 CM CONE. THE INCIDENT WAS DESCRIBED AS FOLLOWS BY THE REPORTING PHYSICIAN; "DURING PLANNING IN THE ARC MODE IT WAS NOTED THAT THE (CIRCULAR) COLLIMATOR OUTLINE OF 30 MM DIAMETER FIELD IS BIGGER THAN THE 32.5 MM FIELD. I CHECKED THE DOSE DISTRIBUTION FOR BOTH FIELDS AND THEY SEEM OK, BUT IT LOOKS STRANGE AND A LITTLE BIT ANNOYING FOR OUR NEUROSURGEON. FOR THE 30 MM FIELD THIS COLLIMATOR OUTLINE IS EQUAL WITH ABOUT THE 50% ISODOSE LINE AND ARE EQUAL WITH ABOUT THE 80% FOR THE OTHERS. INTERESTINGLY WE HAVE THIS PROBLEM ONLY FOR THIS FIELD DIAMETER." THE PHYSICIAN WAS ASKED IF ANY PTS WERE TREATED IF ANY INJURY OCCURRED. THE PHYSICIAN STATED THAT 4 MALES AND 1 FEMALE WERE TREATED USING THIS CONE BUT NONE OF THEM WAS INJURED BECAUSE "WE CHECKED EACH CASE CAREFULLY THE ISODOSE CURVES AND CHOSE THE DIAMETER ACCORDING TO ISODOSES AND NOT TO THE COLLIMATOR OUTLINE." ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XKNIFE RT LINUX WORKSTATION NA KPQ INTEGRA RADIONICS

    Patients

    Seq Age Sex Outcome Treatment
    1