BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 4947366 · Received July 21, 2015

    Report

    Report Number
    1825014-2015-00032
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 21, 2015
    Manufacturer
    DAI-ICHI SHOMEI
    Product Code
    EBA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, HOSPITAL STAFF NOTED WHITE PLASTIC PIECES FLOATING DOWN FROM THE SURGICAL LIGHT INTO THE STERILE FIELD. NO INJURIES WERE REPORTED. THE SURGERY WAS COMPLETED AS SCHEDULED. UPON INVESTIGATION, FACILITY'S BIOMED NOTED THAT THE END CAP OF THE LIGHT WAS DAMAGED AND APPEARED TO BE CHIPPED AWAY FROM USE AND POTENTIAL COLLISION WITH OTHER EQUIPMENT. ALL SURGICAL LIGHTS IN THE FACILITY WERE INSPECTED AND OTHER LIGHTS WERE FOUND TO BE IN A SIMILAR CONDITION. FACILITY ORDERED REPLACEMENT CAPS FOR AND WILL REPLACE THEM UPON RECEIPT. FACILITY IS RETURNING DAMAGED CAPS TO (B)(4) FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472718 SKYTRON SURGICAL LIGHT EBA DAI-ICHI SHOMEI ST23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention