BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOVUE

    MDR report key: 22145578 · Received June 4, 2025

    Report

    Report Number
    2124215-2025-36434
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    April 26, 2024
    Report Date
    June 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4: THE SUSPECTED DEVICE UPN AND LOT NUMBER COULD NOT BE PROVIDED. THE EXACT DEVICE EXPIRATION DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT EXPIRED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE KOO, H. Y., YOO, J. W., KIM, Y. J., JANG, H. K., JEON, B. J., CHOI, H., BAE, J. H., PARK, J. Y., & TAE, B. S. (2024). CUMULATIVE SUM ANALYSIS OF THE LEARNING CURVE FOR RETROGRADE INTRARENAL STONE SURGERY IN NEWBIE SURGEONS. WORLD JOURNAL OF UROLOGY, 42, 261.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC WAS INFORMED VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A RETROSPECTIVE, SINGLE-CENTER STUDY WAS CONDUCTED TO EVALUATE THE LEARNING CURVE OF RETROGRADE INTRARENAL SURGERY (RIRS) AMONG SURGEONS WITH VARYING LEVELS OF EXPERIENCE. THE STUDY ANALYZED THE PERFORMANCE OF ONE EXPERIENCED TUTOR SURGEON AND THREE NOVICE SURGEONS TREATING PATIENTS WITH MID-SIZED KIDNEY STONES. A TOTAL OF 227 PATIENTS WITH ONE OR MORE STONES MEASURING BETWEEN 10-30 MM IN DIAMETER WERE ENROLLED BETWEEN 2019 AND 2022. ALL RIRS PROCEDURES WERE PERFORMED USING A DUAL-LUMEN CATHETER AND THE LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE (BOSTON SCIENTIFIC), ALONG WITH THE LUMENIS PULSE 100H HOLMIUM LASER SYSTEM. FRAGMENTATION EFFICACY WAS CALCULATED AS THE VOLUME OF STONE REMOVED PER MINUTE OF OPERATIVE TIME. CUSUM ANALYSIS WAS USED TO MONITOR CHANGES IN SURGICAL PERFORMANCE AND VALIDATE OUTCOMES. LEARNING CURVE ANALYSIS SHOWED THAT THE THREE NOVICE SURGEONS REACHED A PERFORMANCE PLATEAU AFTER APPROXIMATELY 12-15 CASES. THE FOLLOWING COMPLICATIONS WERE REPORTED POSTOPERATIVE COMPLICATIONS INCLUDED 2 CASES OF SEPSIS, 2 REQUIRING TRANSFUSION, 4 CASES OF ACUTE KIDNEY INJURY (AKI), 3 INTRAOPERATIVE URETERAL INJURIES, AND 1 POSTOPERATIVE URETERAL STRICTURE. THIS REPORT IS PERTAINING TO A LITHOVUE SCOPE WHICH WAS MENTIONED IN THE LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358807 LITHOVUE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown