BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 490075 · Received September 11, 2003

    Report

    Report Number
    490075
    Event Type
    Other
    Date Received
    September 11, 2003
    Date of Event
    November 1, 2002
    Report Date
    December 1, 2002
    Manufacturer
    STERIS CORPORATION
    Product Code
    FSY
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SURGICAL PROCEDURE HAD BEGAN. ALL 4 OVERHEAD STOP LIGHTS WERE ON. A REGISTERED NURSE NOTICED THICK BLACK SMOKE ASCENDING FROM LIGHT BOX 3-4 AND TRAVELING UP THE WALL. THE RN NOTIFIED THE SURGEON, AND TURNED OFF THE LIGHT BOX, WHILE THE 2ND RN NOTIFIED HALL SUPERVISOR. THE SMOKE STOPPED IMMEDIATELY, AFTER TURNING OFF LIGHT BOX. THE LIGHT BOX WAS VERY HOT TO TOUCH. A FIRE EXTINGUISHER WAS BROUGHT WITH IMMEDIATE SUPPORT TEAM RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL LIGHT FSY STERIS CORPORATION OLOO-002-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other