BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 7734563 · Received July 31, 2018

    Report

    Report Number
    3006437518-2015-00006
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Report Date
    May 28, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    FSY
    PMA / PMN Number
    K002463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, DAI-ICHI SHOMEI RECEIVED INFORMATION THAT DURING A PROCEDURE, THE ACRYLIC COVER OF THE SURGICAL LIGHT FELL OVER THE PATIENT'S INCISION AREA. STAFF REMOVED PIECES OF GLASS FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579538 SKYTRON SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO., LTD ST23

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention