BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XKNIFE RT LINUX WORKSTATION

    MDR report key: 1734729 · Received June 22, 2010

    Report

    Report Number
    1222895-2010-00005
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    INTEGRA RADIONICS
    Product Code
    MUJ
    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 WILL NOT BE 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 30.0MM CONE IN THE SITE'S BEAM DATA FILE HAD BEEN INCORRECTLY SET TO 37.5MM. OTHER PARAMETERS FOR THE 30.0MM CONE WERE FOUND TO BE CORRECT. ADD'L INFO HAS BEEN REQUESTED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    SINCE THE 30.0MM CONE WAS USED ON FIVE PTS AND WHILE THERE WAS AN ERROR WITH THE SITE'S BEAM DATA FILE, INTEGRA IS SUBMITTING A MEDWATCH FOR EACH PT. THIS REPORT IS THE SECOND REPORT OF FIVE. THE FIRST REPORT WAS SENT UNDER MDR REF# 1222895-2010-00004 (2010-04-0491, PR (B)(4)). XKNIFE RT LINUX WORKSTATION; THE OUTLINE OF THE 3CM CONE IN THE SOFTWARE APPEARED BIGGER THAN THE 3.5CM CONE. THIS REPORT INVOLVED MALE PT #1. 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 30MM DIAMETER FIELD IS BIGGER THAN THE 32.5MM 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 30MM 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 AND 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." ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1