BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1944288 · Received December 6, 2010

    Report

    Report Number
    3003793371-2010-00035
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K010975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED A DESIGN LIMITATION IN RAPIDARC VERSION 8.6, WHERE A PLAN CAN BE CREATED WITH A 45 DEGREES COLLIMATOR ANGLE AND A SQUARE JAW SETTING, RESULTING IN A LEAF PAIR WITH A DOSE DYNAMIC LEAF GAP AT THE EDGE OF THE X1 JAW FOR MOST OF THE BEAM DELIVERY. THIS LEAF GAP CAN DELIVER UNINTENDED DOSE TO THIS SPOT OF UP TO 33% OF THE PRESCRIBED DOSE. UNINTENDED DOSE TO NORMAL TISSUES CAN LEAD TO INCREASED TOXICITY DURING THE TREATMENT COURSE. THE MOST SERIOUS EFFECT WOULD BE TO HAVE THIS SPOT OF UNINTENDED DOSE LOCATED WITHIN A CRITICAL STRUCTURE THAT IS ALSO BEING TREATED BY AN ABUTTING TREATMENT PLAN, WITH DOSE CONTRIBUTION FROM BOTH PLANS. HOWEVER, NO MISADMINISTRATION OCCURRED IN THIS CASE - THE PROBLEM WAS DETECTED DURING PLAN QA, PRIOR TO THE TREATMENT. DOSE DOT IS CLEARLY VISIBLE IN ECLIPSE EXTERNAL BEAM PLANNING, FIELD SET UP WORKSPACE. IT WILL APPEAR IN THE ISODOSE DISTRIBUTION AND DVH IF THE DOSE IS IN A REGION IN WHICH CRITICAL STRUCTURE IS CONTOURED. THE DESIGN LIMITATION FOUND IN 8.6 HAS BEEN ADDRESSED IN CURRENT VERSIONS. A CUSTOMER TECHNICAL BULLETIN WILL BE SENT TO AFFECTED CUSTOMERS TO PROVIDE CLARIFICATION AND FURTHER INSTRUCTIONS REGARDING THIS ISSUE. NO F/U REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RAPID ARC MLC SEQUENCE LEAVES OPEN AREAS AWAY FROM TARGET. THE CUSTOMER HAS A 2 ARC RAPID ARC PLAN. HE REPORTS THAT, WHEN REVIEWING THE MLC LEAF TRAVEL, THERE ARE UNBLOCKED AREAS WITHIN THE FIELD APERTURE NEAR THE Y1 AND Y2 FIELD EDGES. NO SERIOUS INJURY TO THE PT WAS REPORTED, AS THE USER OBSERVED THIS EVENT DURING THE QA PROCESS IN THE PLAN EVAL OF THE MLC LEAF SEQUENCE. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1