BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 7734562 · Received July 31, 2018

    Report

    Report Number
    3006437518-2015-00004
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    June 19, 2014
    Report Date
    May 25, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    FSY
    Product Problem
    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, A STAFF MEMBER WAS ADJUSTING THE LIGHT ARM. THE ARM COVER ABOVE THE SPINDLE BECAME LOOSE AND FELL. DUST ENTERED THE PATIENT'S INCISION AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579523 SKYTRON SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO., LTD AUR55

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown