BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 8854247 · Received August 2, 2019

    Report

    Report Number
    8010047-2019-02810
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 28, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    UDI-DI
    04953170403835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO (B)(4). (B)(4) EVALUATED THE SUBJECT DEVICE AND CONFIRMED THAT BLACK DOTS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE AND THERE WAS A CRACK ON THE LENS OF THE SUBJECT DEVICE. 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. ON AUGUST 6TH, 2019, OLYMPUS MEDICAL SYSTEMS (B)(4) ADDITIONALLY EVALUATED THE SUBJECT DEVICE AND THE ADDITIONAL EVALUATION RESULTS WERE AS FOLLOWS; THERE WAS A LEAK FROM THE OBJECT LENS. THERE WAS A BURN MARK AT THE DISTAL END. THERE WAS CORROSION INSIDE THE BENDING TUBE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. CONSIDERING THE BURN MARK AT THE DISTAL END, IT IS LIKELY THAT THE IMAGE FIBER BREAKAGE, LENS CRACKING, AND LEAKAGE FROM THE OBJECT LENS OCCURRED DUE TO ERRONEOUS IRRADIATION OF THE LASER INSIDE THE SUBJECT DEVICE. IT IS SURMISED THAT THE REPORTED EVENT OCCURRED DUE TO THE IMAGE FIBER BREAKAGE. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY WARNED AS FOLLOWS; DO NOT IRRADIATE THE LASER WITHOUT VIEWING THE TIP OF THE LASER PROBE AND THE AIMING BEAM IN THE ENDOSCOPIC IMAGE. THIS MAY CAUSE PATIENT INJURY, AND THE INSTRUMENT CHANNEL MAY BE DAMAGED. DO NOT WITHDRAW THE LASER PROBE WHILE IRRADIATING THE LASER. PATIENT INJURY AND/OR ENDOSCOPE DAMAGE MAY OCCUR.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A RETROGRADE INTRARENAL SURGERY, BLACK DOTS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE. IT WAS REPORTED THAT THE USER FACILITY WAS USING A LASER DEVICE WHEN THE EVENT OCCURRED. THE USER FACILITY CHANGED THE SUBJECT DEVICE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649285 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P7R 04953170403835

    Patients

    Seq Age Sex Outcome Treatment
    1