BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM, UROLOGY

    MDR report key: 18813288 · Received February 29, 2024

    Report

    Report Number
    3014447948-2024-00002
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 18, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    FGB
    PMA / PMN Number
    K213334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY AURIS HEALTH, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, AURIS HEALTH, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    IN INVESTIGATION OF RETURNED PRODUCT, IT WAS DISCOVERED THAT AT LEAST ONE LAYER OF THE CAMERA LENS STACK HAD DELAMINATED, LEAVING A VACANT RECTANGULAR HOLE IN THE URETEROSCOPE TIP. REVIEW OF CASE VIDEO IDENTIFIED THERE WAS A USER ERROR WHICH VIOLATED OUR IFUS. THE USER WAS ACTUATING THE LASER FIBER AND COMMANDED LASER FIBER RETRACTING. THE LASER FIBER WAS NOT VISIBLE IN THE CAMERA IMAGE AS IT WAS FIRED. OUR IFUS STATE THAT THE LASER FIBER MUST ONLY BE ACTUATED WHEN THE FIBER TAKES UP ~1/3 OF THE CAMERA FIELD OF VIEW (FOV). THE IMAGE BLURRINESS BEGAN IMMEDIATELY AFTER THIS EVENT. IT WAS IDENTIFIED THAT THIS DELAMINATION OCCURRED DUE TO THIS ERRONEOUS USE OF THE LASER.

    Description of Event or Problem · 0

    DURING THE CLINICAL STUDY TRIAL CASE UNEXPECTED VIDEO QUALITY WAS OBSERVED ON URETEROSCOPE. THE UNEXPECTED VIDEO QUALITY CONSISTED OF BLURRINESS ON THE SYSTEM DISPLAY. THE BLURRY VISION WAS ONLY OBSERVED DURING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE OF THE PRODUCT WORKFLOW, NAMELY DURING URETEROSCOPE DRIVING WITH THE LASER DRIVER COMPONENT CONNECTED. UPON REPLACEMENT OF THE URETEROSCOPE, NO FURTHER VIDEO ISSUES WERE OBSERVED AND THE USER COMPLETED THE CASE. UNDER PRELIMINARY INVESTIGATION THE URETEROSCOPE WAS EXAMINED UNDER MAGNIFICATION, AT WHICH TIME IT WAS DISCOVERED THAT THE TOP LAYER OF THE CAMERA LENS WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910445 MONARCH PLATFORM, UROLOGY URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB AURIS HEALTH, INC. MUR-000011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other