BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN HIGH ENERGY LINEAR ACCELERATOR

    MDR report key: 3591469 · Received January 10, 2014

    Report

    Report Number
    2916710-2014-00002
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 18, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    PMA / PMN Number
    K112839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE DETERMINED TO BE CAUSED BY USER ERROR WITH NO EQUIPMENT MALFUNCTION. NO ADDITIONAL FOLLOW UP FROM VARIAN FOR THIS MDR.

    Description of Event or Problem · 1

    THE STAFF THERAPIST WAS PLACING A WEDGE INTO THE LINEAR ACCELERATOR AND PUSHED THE WEDGE STRONGLY WITHOUT REMOVING HIS LEFT HAND WHICH WAS IN BETWEEN THE WEDGE AND THE WEDGE INTERFACE MOUNT. THIS RESULTED IN A BROKEN FINGER THAT REQUIRED MEDICAL INTERVENTION. ISSUE WAS FOUND TO BE ATTRIBUTED TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20588 VARIAN HIGH ENERGY LINEAR ACCELERATOR CLINAC 2100C IYE VARIAN MEDICAL SYSTEMS, INC H27

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention