BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON STELLAR XL

    MDR report key: 12382474 · Received August 30, 2021

    Report

    Report Number
    3006437518-2021-00002
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 27, 2021
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON AUGUST 20, 2021 DKK WAS REPORTED BY THE IMPORTER THAT A STELLAR XL DUAL WALL CONTROL ON/OFF SWITCH FAILED AND THERE WAS A SPARK AT THE TIME OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286217 SKYTRON STELLAR XL SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO., LTD B6-010-12

    Patients

    Seq Age Sex Outcome Treatment
    1