BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON STELLAR XL

    MDR report key: 15518699 · Received September 30, 2022

    Report

    Report Number
    3006437518-2022-00002
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    February 10, 2022
    Report Date
    September 7, 2022
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DISTRIBUTOR, IMPROPER CLEANING BY CLEANING STAFF AT THE HOSPITAL MIGHT HAVE CAUSED THIS ISSUE, BUT DUE TO THE HIGH TURNOVER WITH CLEANING STAFF IT WAS UNABLE TO CONFIRM THE CLEANING PROCESS USED FOR AFFECTED DEVICES.

    Description of Event or Problem · 0

    ON (B)(6) 2022, DKK WAS INFORMED THAT SURGICAL LIGHTS AT (B)(6) HOSPITAL AND CLINIC HAD EXPERIENCED RUSTING IN THE JOINTS AND CORROSION AND FLAKING OF POWER COATING. MAJORITY OF RUSTING AND DAMAGE WERE PRESENT IN CREVICES OF LIGHT HEAD AND COMPONENTS, WITH PAINT FLAKING ON COMPONENTS UP HIGH SUCH AS LOWER MONITOR ARM HUBS AND LIGHT SPINDLES. NO PATIENT INVOLVEMENT OR INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185592 SKYTRON STELLAR XL LIGHT, SURGICAL, ACCESSORIES FTA DAI-ICHI SHOMEI CO., LTD. STX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown