BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SURGICAL LIGHT

    MDR report key: 1994150 · Received February 16, 2011

    Report

    Report Number
    1043572-2011-00016
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    PMA / PMN Number
    K823360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE LIGHTING SYSTEM AND FOUND IT TO BE PROPERLY OPERATING. THE LIGHTING SYSTEM IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY'S BIOMEDICAL DEPARTMENT. THE OPERATOR MANUAL CONTAINS THE FOLLOWING WARNING CONCERNING LAMP REPLACEMENT: "WARNING - ELECTRIC SHOCK AND BURN HAZARD: BE SURE REFLECTOR OUTER COVER AND LAMP HOLDER ARE COOL BEFORE TOUCHING." THE USER FACILITY HAS ACCEPTED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SURGICAL LIGHTING SYSTEM.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING PREPARATION FOR A PATIENT PROCEDURE WHEN THE SURGICAL LIGHTS WERE TURNED ON ONE OF THE TWO LIGHTHEADS GLOWED DIMLY. A NURSE THEN SHUT THE POWER OFF TO THE LIGHTHEAD, TOUCHED THE LIGHTHEAD'S LAMP TO REMOVE IT, AND RECEIVED A BURN ON HER FINGER AND THUMB. THE NURSE RAN HER FINGER AND THUMB UNDER COLD WATER AND A FACILITY DOCTOR APPLIED SILVADENE OINTMENT. THE NURSE THEN WENT TO THE FACILITY EMERGENCY ROOM WHERE SHE RECEIVED A TETANUS SHOT AND BACITRACIN OINTMENT. THE NURSE HAS FULLY RECOVERED AND HAS NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS SURGICAL LIGHT SURGICAL LIGHT FTD STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other