BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOTHERAPY HI-ART TREATMENT SYSTEM

    MDR report key: 6140277 · Received December 1, 2016

    Report

    Report Number
    3003873069-2016-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 2, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    UDI-DI
    M6581043090
    PMA / PMN Number
    K121934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING A FLEX PIVOT JOINT FAILURE. THE PRIMARY COLLIMATION SYSTEM IS COMPRISED OF TWO JAWS THAT CONTROL THE WIDTH (THICKNESS) OF THE RADIATION BEAM. THE TWO HALVES OF THE JAW ARE OPENED AND CLOSED WITH ELECTRIC ACTUATORS. THESE ACTUATORS ARE HELD ON MOUNTING BRACKETS BY FLEX PIVOTS WHICH ALLOW ROTATION WHILE PROVIDING A TIGHT FIT. IN THIS CASE, THE FLEX PIVOT JOINTS CRACKED (LIKELY DUE TO A TORQUE ISSUE), AND THE WIDTH OF THE RADIATION BEAM WAS NOT APPROPRIATELY COLLIMATED RESULTING IN UNDER-DOSE BY 2-11%. SUBSEQUENT COMPENSATING FRACTIONS WERE DELIVERED ACCORDING TO A PHYSICIAN APPROVED TREATMENT PLAN. WE WERE INFORMED THAT THE CUSTOMER/USER SUBMITTED A MEDWATCH REPORT.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING A FLEX PIVOT JOINT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790659 TOMOTHERAPY HI-ART TREATMENT SYSTEM TOMOTHERAPY TREATMENT SYSTEM IYE ACCURAY INCORPORATED H-0000-0003 N/A M6581043090

    Patients

    Seq Age Sex Outcome Treatment
    1