BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 8820671 · Received July 24, 2019

    Report

    Report Number
    8010047-2019-02674
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K181451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS EUROPA K.G (OEKG) FOR EVALUATION. IN THE EVALUATION, OEKG CONFIRMED THE FOLLOWINGS; - THE FIBERS FOR TRANSMITTING IMAGE WERE BROKEN. - THE BENDING SECTION WAS BROKEN AND THE CABLE SUPPORTS OF THE BENDING TUBE WERE DETACHED. - THE VENTING CONNECTOR WAS LOOSE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE ANGULATION OF THE SUBJECT DEVICE WAS BROKEN AND SOME BLACK DOTS APPEARED ON THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS ABORTED AND RESCHEDULED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617056 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P7

    Patients

    Seq Age Sex Outcome Treatment
    1