BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 4210249 · Received October 21, 2014

    Report

    Report Number
    1825014-2014-00014
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    January 3, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DDK
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A THORACOTOMY A SURGICAL LIGHT WAS BROUGHT INTO THE FIELD AND THE LENS OPENED. REFLECTIVE MATERIAL FROM THE LENS WAS ABLE TO ENTER THE SURGICAL SITE. IT IS SUSPECTED THAT SOME PARTICLES DID LAND INSIDE THE PT. THE SURGEON ALSO NOTED WHAT SEEMED LIKE DUST IN HIS EYES FOLLOWING THE INCIDENT. BEFORE CLOSING THE CASE SKYTRON INFORMED THE SURGEON THAT THE MATERIALS MAKING UP THE REFLECTIVE MATERIAL WAS SIO AND TIO (SILICON MONOXIDE AND TITANIUM MONOXIDE RESPECTIVELY). THE SURGEON PROCEEDED WITH THE CASE AND CLOSED THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670250 SKYTRON SURGICAL LIGHT BWN DDK ST23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention