BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN CL-IXS TRILOGY

    MDR report key: 4287692 · Received November 24, 2014

    Report

    Report Number
    2916710-2014-00007
    Event Type
    Injury
    Date Received
    November 24, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 3, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC.
    Product Code
    IYE
    PMA / PMN Number
    K072916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO FAILURE OR MALFUNCTION OF VARIAN HARDWARE OR SOFTWARE. THE CUSTOMER WAS UNABLE TO SUPPORT THE WEIGHT OF THE WEDGE DURING THE PROCESS OF REMOVAL. NO ADDITIONAL F/U TO THIS REPORT IS ANTICIPATED. VARIA REFERENCE (B)(4).

    Description of Event or Problem · 1

    A THERAPIST WAS REMOVING A 30 DEGREE WEDGE FROM THE I/F MOUNT AND SHE WAS UNABLE TO SUPPORT THE WEIGHT OF THE ACCESSORY. SHE TRIED TO CONTROL THE DESCENT; HOWEVER, WAS NOT SUCCESSFUL. SHE HIT THE COUCH AND THE IMPACT FRACTURED THE FIRST PHALANX OF HER FIFTH FINGER. X-RAYS WERE TAKEN AND A PLASTER CAST WAS APPLIED TO HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761789 VARIAN CL-IXS TRILOGY TRILOGY SYSTEM WITH RAPIDARC IYE VARIAN MEDICAL SYSTEMS INC. H14

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention