BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLAR SERIES

    MDR report key: 10165980 · Received June 17, 2020

    Report

    Report Number
    3006437518-2020-00002
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    July 15, 2015
    Report Date
    June 9, 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

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE REVIEWING THE OLD MDRS, DAI-ICHI SHOMEI (DKK) REALIZED THAT TWO FOLLOW-UP REPORTS HAD BEEN SUBMITTED WITHOUT INITIAL REPORTS. FURTHER, THE SAME REPORT NUMBER 3006437518-2018-00001 WAS ERRONEOUSLY ASSINGED TO THE TWO FOLLOW-UP REPORTS. DKK SUBMITTED AN INITIAL REPORT FOR ONE OF THE FOLLOW-UP REPORTS WITH THE REPORT NUMBER 3006437518-2018-00001 AND SUBMITTED THIS INITIAL REPORT FOR THE OTHER FOLLOW-UP REPORT. TO MAKE A DISTINCTION, A NEW REPORT NUMBER 3006437518-2020-00002 WAS ASSIGNED TO THIS INITIAL REPORT. DKK ALSO MADE SOME CORRECTIONS ON THE INFORMATION PROVIDED IN THE FOLLOW-UP REPORT AS FOLLOWING: BRAND NAME: CHANGED TO STELLAR SERIES FROM SKYTRON. MODEL #: CHANGED TO ST2323 FROM B1-710-73.

    Description of Event or Problem · 1

    ON SEPTEMBER 4, 2015, DAI-ICHI SHOMEI RECEIVED INFORMATION THAT DURING A PROCEDURE THE ACRYLIC COVER AND LENS OPENED, AND DUST FELL OVER THE OPERATIVE SITE FROM THE SURGICAL LIGHT. DUST DID NOT ENTER THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629821 STELLAR SERIES SURGICAL LIGHT ACCESSORY FSY DAI-ICHI SHOMEI CO., LTD ST2323

    Patients

    Seq Age Sex Outcome Treatment
    1 Other