BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISION SINGLE CHAMBER WASHER

    MDR report key: 2113768 · Received June 3, 2011

    Report

    Report Number
    9680353-2011-00012
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE REPRESENTATIVE INSPECTED THE VISION SINGLE CHAMBER WASHER AND COULD NOT DUPLICATE THE REPORTED EVENT; NO ISSUES WERE NOTED WITH THE EQUIPMENT. THE TECHNICIAN VERIFIED THE WASHER DOOR AND SWITCHES WERE OPERATING PROPERLY. THE WASHER OPERATOR MANUAL STATES (PP 4-35): " WARNING - BURN HAZARD: IF AN OBSTRUCTION IS PRESENT IN THE CHAMBER DOOR, DO NOT ATTEMPT TO REMOVE THE OBJECT. DOOR AUTOMATICALLY RAISES AND REMAINS OPEN. HOT WATER AND STEAM MAY BE SPRAYED THROUGH DOOR OPENING. ALWAYS WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT AND WAIT FOR WATER FLOW TO STOP." STERIS HAS SCHEDULED IN-SERVICE TRAINING REGARDING THE PROPER USE AND OPERATION OF THE EQUIPMENT FOR (B)(4), 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE INJURED HIS HAND WHILE TRYING TO FREE A WASH MANIFOLD FROM A RELIANCE VISION SINGLE CHAMBER WASHER. THE OPERATOR MANUALLY ATTEMPTED TO PUSH THE MANIFOLD INTO THE WASHER, ALLOWING THE CHAMBER DOOR TO FALL ON HIS HAND, CAUSING BRUISING. THE OPERATOR WENT TO THE FACILITY EMERGENCY ROOM WHERE HE RECEIVED AN X-RAY AND WAS PUT ON LIGHT WORK DUTY. THE USER FACILITY REPORTS THE OPERATOR HAS FULLY RECOVERED AND HAS RETURNED TO NORMAL WORK DUTIES..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION SINGLE CHAMBER WASHER WASHER/DISINFECTOR MEC STERIS CANADA CORPORATION 1932982

    Patients

    Seq Age Sex Outcome Treatment
    1 Other