BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 9080499 · Received September 18, 2019

    Report

    Report Number
    8010047-2019-03312
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Report Date
    October 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K181451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. DURING THE EVALUATION, OMSC CONFIRMED THAT THE REPORTED ABNORMALITY IN ANGULATION CONTROL. OMSC DISASSEMBLED THE CONTROL SECTION OF THE DEVICE AND CONFIRMED CORROSION OF THE METAL COMPONENTS INSIDE THE CONTROL SECTION. IN ADDITION, IT WAS CONFIRMED THAT THERE WAS PITCH DEVIATION OF THE COIL PIPE THROUGH WHICH THE ANGLE WIRE. 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. IT WAS CONFIRMED THAT THE BENDING SECTION OF THE SUBJECT DEVICE WAS LOCKED IN DOWN DIRECTION. 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 USER FACILITY NOTICED BLACK DOTS IN ENDOSCOPIC IMAGE AND AN ABNORMALITY OF THE BENDING MECHANISM DURING A PATIENT PROCEDURE USING THE SUBJECT DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878779 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P7

    Patients

    Seq Age Sex Outcome Treatment
    1