BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 8673042 · Received June 5, 2019

    Report

    Report Number
    8010047-2019-02122
    Event Type
    Injury
    Date Received
    June 5, 2019
    Report Date
    June 6, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    UDI-DI
    04953170343582
    PMA / PMN Number
    K172246
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC. OMSC COULD NOT REVIEW SERVICE AND MANUFACTURING RECORDS BECAUSE THE SERIAL NUMBERS OF THE SUBJECT DEVICES WERE NOT PROVIDED FROM THE FACILITY. AS PART OF OUR INVESTIGATION, OMSC REVIEWED ALL OF THE COMPLAINTS, BUT THERE WAS NO RECORD ASSOCIATED WITH THE EVENT DESCRIBED IN THE ARTICLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON MAY 8, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿IN VITRO AND IN VIVO NEW EVIDENCE FOR FLEXOR VUE DEFLECTING ENDOSCOPIC SYSTEM USE: OPTIMIZATION OF THE STONE FREE RATE (SFR) AFTER RIRS¿. THE LITERATURE REPORTED THE RESULT OF 11 CASES OF USING FLEXOR VUE DEFLECTING ENDOSCOPE SYSTEM (FVDES, COOK) TO IMPROVE STONE FREE RATE (SFR) AFTER PREFORMING RETROGRADE INTRARENAL SURGERY (RIRS) USING OLYMPUS URETERO-RENO VIDEOSCOPE URF-V2. IN THE SUBJECT CASES, ONE PATIENT HAD FEVER AND REQUIRED ANTIBIOTIC TREATMENT FOR FIVE DAYS. OMSC IS SUBMITTING ONE MDR ACCORDING TO THE NUMBER OF THE COMPLICATION CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465433 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2 04953170343582

    Patients

    Seq Age Sex Outcome Treatment
    1