BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC

    MDR report key: 1050153 · Received May 20, 2008

    Report

    Report Number
    2916710-2008-00022
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 14, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3- DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION WAS NECESSARY. RESULTS: THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSIONS: DEVICE OPERATED ACCORDING TO SPECIFICATIONS. NO DEVICE FAILURE. USER ERROR CAUSED EVENT. USER ERROR CONTRIBUTED TO EVENT. VARIAN HAS DEVELOPED A DESIGN ENHANCEMENT TO THE EXACT COUCH TOP, WHICH INCLUDES A MYLAR SHEET ATTACHED TO THE UNDERSIDE OF THE EXACT COUCH TOP THAT PREVENTS ACCESS TO THE PINCH HAZARD AREAS. THE EXACT COUCH USER GUIDE/MAINTENANCE MANUAL (SECT. 3-10) ALSO INCLUDES WARNINGS ON THE PRESENCE OF PINCH POINTS.

    Description of Event or Problem · 1

    THE USER TRIED TO RETRACT THE EXACT COUCH TOP MANUALLY, BUT CAUGHT HIS RIGHT PINKY FINGER IN THE PINCH POINT. THE INCIDENT REQUIRED FOUR (4) SUTURES TO MEND THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS CL-21EX

    Patients

    Seq Age Sex Outcome Treatment
    1