BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XKNIFE 5.0 INSTALL KIT

    MDR report key: 2854349 · Received November 28, 2012

    Report

    Report Number
    1222895-2012-00052
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA INC
    Product Code
    MUJ
    PMA / PMN Number
    K100417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    XKNIFE IS A RADIOSURGERY AND RADIOTHERAPY TREATMENT PLANNING SYSTEM INTENDED FOR USE IN STEREOTACTIC (FRAMELESS STEREOTACTIC) COLLIMATED BEAM, COMPUTER PLANNED, LINEAR ACCELERATOR (LINAC) BASED TREATMENT. THE SOFTWARE INSTALLATION IS CONDUCTED PRIOR TO SCHEDULING THE USE OF THE SYSTEM TO TREAT PTS. THEREFORE, THERE WAS NO PT CONTACT. INVESTIGATIVE FINDINGS INCLUDED THE FOLLOWING: COMPLAINT HAS BEEN CONFIRMED WITH TECHNICAL SERVICE AS A KNOWN ISSUE, AFFECTING XKNIFE V5.0.1 AND V5.0.2 WITH CUSTOMERS THAT OPERATE WITH A IEC6010 LINAC. AN ADVERSE TREND HAS BEEN IDENTIFIED ASSOCIATED WITH THIS "SOFTWARE BUG." CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE ROOT CAUSE AND DETERMINE APPROPRIATE CORRECTIVE ACTION. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    JAW ARITHMETIC SIGN WRONG WHEN IMPORTING DICOM-RT PLAN DUE TO SOFTWARE ERROR." THE ERROR MESSAGE OCCURS IN THE "(B)(4)" SYSTEM. THE (B)(4) SYSTEM IS THIRD PARTY SOFTWARE INTEGRATED WITH THE LINAC THAT VERIFIES THE PROPER POSITION OF THE COUCH, COLLIMATOR, GANTRY AND ANY BEAM MODIFIERS BEFORE TREATMENT IS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XKNIFE 5.0 INSTALL KIT NEURO MUJ INTEGRA BURLINGTON, MA INC

    Patients

    Seq Age Sex Outcome Treatment
    1