BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON STELLAR XL

    MDR report key: 15518553 · Received September 30, 2022

    Report

    Report Number
    3006437518-2022-00003
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 7, 2022
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FAILURE IS REPRESENTATIVE OF LIGHTS AND COMPONENTS NOT BEING CLEANED ACCORDING TO MANUFACTURER SPECIFICATIONS, TYPICALLY BEING OVERLY SATURATED AND ALLOWED TO AIR DRY. NO SERIAL NUMBER IS PRESENT ON THE AFFECTED COMPONENTS, WHICH WERE BELIEVED TO BE INSTALLED IN 2004. IMPROPER CLEANING PRACTICES THROUGHOUT THIS AMOUNT OF TIME MAY ALLOW DEGRADING OF THE LABELING CONTAINING THE SERIAL INFORMATION OF THE COMPONENTS.

    Description of Event or Problem · 0

    ON SEPTEMBER 7, 2022, DKK WAS INFORMED THAT RADIAL ARM AND LFS HUBS AT (B)(4) WERE EXPERIENCING RUSTING AND FLAKING OF POWDER COATING. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A PAINT CHIP FELL INTO AN OPEN INCISION. THE CHIP WAS REMOVED AND THE INCISION WAS CLEANED - NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478081 SKYTRON STELLAR XL LIGHT, SURGICAL, ACCESSORIES FTA DAI-ICHI SHOMEI CO., LTD. STX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown