BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODYSSEY

    MDR report key: 1647727 · Received March 26, 2010

    Report

    Report Number
    2032139-2010-00003
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 23, 2010
    Manufacturer
    PERMEDICS INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN URGENT MEDICAL DEVICE CORRECTION LETTER WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS, WITH A DESCRIPTION OF THE ANOMALY AND USER CORRECTIVE ACTION STEPS. THE LETTER WILL ALSO BE DISTRIBUTED TO THE PERMEDICS SALES ORGANIZATIONS, INFORMING THEM OF THE ISSUE. A MANDATORY UPGRADE WILL BE PROVIDED BY (B)(4) 2010 AT NO CHARGE. IN THE MEANTIME, THE FOLLOWING RECOMMENDATIONS ARE PROVIDED; ODYSSEY MLC BLOCK ERROR, IT IS RECOMMENDED TO AVOID USING THE MLC BLOCK FEATURE UNTIL THE MANDATORY VERSION CORRECTING THIS ANOMALY IS INSTALLED. IF YOU NEED TO USE THIS FEATURE, THEN IT IS RECOMMENDED THAT A PHYSICAL BLOCK TRAY IS USED DURING TREATMENT FOR EACH BEAM THAT CONTAINS AN ODYSSEY MLC BLOCK.

    Description of Event or Problem · 1

    ANOMALY, ODYSSEY MLC BLOCK ERROR: ODYSSEY ALLOWS THE USER TO ADD AN ODYSSEY MLC BLOCK (A VIRTUAL BLOCK) TO MOVE THE MLC LEAVES AUTOMATICALLY TO COVER A SELECTED TISSUE REGION. WHEN A VIRTUAL BLOCK IS USED, A BLOCK TRAY WOULD NOT BE EXPECTED IN SETUP; HOWEVER, ODYSSEY CURRENTLY CONSIDERS A BLOCK TRAY TRANSMISSION FACTOR WHEN CALCULATING DOSE WITH AN ODYSSEY MLC BLOCK. THE DOSE CAN BE OFF BY AS MUCH AS A TRAY FACTOR, WHICH IS TYPICALLY 2-5%, DEPENDING ON BEAM ENERGY. THE USE OF THE TRAY FACTOR USED IS CLEARLY INDICATED ON THE DICOM RT PLAN AND ODYSSEY REPORT EXPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODYSSEY RADIATION TREATMENT PLANNING SYSTEM MUJ PERMEDICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1