BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLAR SERIES

    MDR report key: 10210386 · Received June 29, 2020

    Report

    Report Number
    3006437518-2018-00002
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    November 3, 2015
    Report Date
    July 8, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FSY
    PMA / PMN Number
    K002463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE IMPORTER'S EVALUATION, THE ORIGINAL OEM PARTS WERE NOT USED BY AUTHORIZED REPRESENTATIVE.

    Description of Event or Problem · 1

    ON DECEMBER 15, 2015, DAI-ICHI SHOMEI (B)(4) RECEIVED INFORMATION THAT THE SURGICAL LIGHT GENERATED SMOKE, A MECHANICAL ODOR, AND STOPPED OPERATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674270 STELLAR SERIES LIGHT, SURGICAL, CEILING MOUNTED FSY DAI-ICHI SHOMEI CO., LTD. ST29TVLH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other