BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES URETERO-RENO FIBERSCOPE

    MDR report key: 8007873 · Received October 26, 2018

    Report

    Report Number
    8010047-2018-02054
    Event Type
    Injury
    Date Received
    October 26, 2018
    Report Date
    October 26, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K912120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE CONCERNING THE EVENTS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ON SEPTEMBER 27, 2018, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY ON TUL TREATMENT OUTCOME FOR KIDNEY STONES AND URETERAL STONE IN OUR HOSPITAL¿. THE LITERATURE REPORTED THE RESULT OF TUL (TRANSURETHRAL LITHOTOMY) PROCEDURES USING OLYMPUS URETERO-RENO VIDEOSCOPE (URF-P5) WITH AN NON OLYMPUS HO:YAG LASER FOR 70 CASES AT THE USER FACILITY BETWEEN JANUARY 2017 AND JANUARY 2018. IN THE SUBJECT PROCEDURES, ACUTE PYELONEPHRITIS (2 CASES) AND INTRAOPERATIVE URETERAL INJURY (2 CASES) OCCURRED. FURTHER DETAILED INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY AT PRESENT. THEREFORE, ACCORDING TO THE NUMBER OF THE TYPE OF COMPLICATION (ACUTE PYELONEPHRITIS AND INTRAOPERATIVE URETERAL INJURY), OMSC IS SUBMITTING 2 MEDICAL DEVICE REPORTS. THIS IS A REPORT ON INTRAOPERATIVE INJURY. (2 OF 2 REPORTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849058 OES URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other