BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 7734573 · Received July 31, 2018

    Report

    Report Number
    3006437518-2015-00010
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Report Date
    May 29, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    FSY
    PMA / PMN Number
    K002463
    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 A NURSE WAS MANEUVERING A MICROSCOPE INTO POSITION FOR THE PROCEDURE WHEN THE TOP COVER OF A SURGICAL LIGHT FELL FROM THE FIXTURE WHILE THE PATIENT WAS ON THE SURGICAL TABLE. THE NURSE DID NOT WITNESS THE COVER FALL, BUT HEARD IT HIT THE FLOOR. THE PATIENT HAD MINOR SCRATCHES ON THEIR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579542 SKYTRON SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO., LTD ST23LH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown