BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 22065621 · Received May 21, 2025

    Report

    Report Number
    3011050570-2025-00526
    Event Type
    Injury
    Date Received
    May 21, 2025
    Report Date
    June 5, 2025
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTS OF THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "WITH GREAT POWER COMES GREAT RISK: HIGH URETERAL STRICTURE RATE AFTER HIGH-POWER, HIGH-FREQUENCY THULIUM FIBER LASER LITHOTRIPSY IN URETEROSCOPY". LITERATURE SUMMARY ABSTRACT TO COMPARE THE SAFETY AND EFFICACY OF THULIUM FIBER LASER (TFL) USING EITHER MANUFACTURER PRESETS (MP) OR INDIVIDUALIZED PRESETS (IP) IN URETEROSCOPY. METHODS: MULTI-INSTITUTIONAL, RETROSPECTIVE ANALYSIS ON THE FIRST PATIENTS TREATED WITH SOLTIVE® PREMIUM (OLYMPUS MEDICAL SYSTEMS®) TFL IN SWITZERLAND IN 2020. MP WERE USED AT THE UNIVERSITY HOSPITAL OF GENEVA, WHILE IP WERE USED AT THE UNIVERSITY HOSPITAL OF ZURICH. PATIENT DEMOGRAPHICS, STONE CHARACTERISTICS, AND PROCEDURAL DETAILS WERE COLLECTED. PRIMARY OUTCOME WAS POSTOPERATIVE URETERAL STRICTURE (US). SECONDARY OUTCOME WAS STONE-FREE RATE (SFR). RESULTS: A TOTAL OF 158 PATIENTS WERE ANALYZED, 79 IN EACH GROUP. DEMOGRAPHICS WERE SIMILAR BETWEEN THE TWO GROUPS, EXCEPT FOR A LOWER PRE-STENTING RATE IN THE MP GROUP (56% VS. 91%; P<0.001) AND A HIGHER RATE OF URETERAL ACCESS SHEATH USE IN THE MP GROUP (65% VS. 44%; P=0.011). NO SIGNIFICANT DIFFERENCES IN STONE BURDEN (MEDIAN STONE DIAMETER 9 MM, MEDIAN STONE VOLUME 267 MM3), NOR IN THE RATE OF IMPACTED URETERAL STONES (29% VS. 34%; P=0.49). MEAN POWER, MAXIMAL POWER, FREQUENCY SETTINGS, AND ENERGY CONSUMPTION WERE SIGNIFICANTLY HIGHER IN THE MP GROUP. US RATE WAS 11% IN MP GROUP COMPARED TO 1% IN IP GROUP (P=0.009). MP WERE A SIGNIFICANT PREDICTOR OF US ON MULTIVARIABLE ANALYSIS (OR 12.4; P=0.02), INDEPENDENTLY FROM IMPACTED URETERAL STONES. NO DIFFERENCE IN SFR BETWEEN GROUPS (85% AND 84%; P=0.67). ADVERSE EVENT: THE PATIENT EXPERIENCED A MID-URETER STRICTURE THAT REQUIRED BALLOON DILATION. CONCLUSION: HIGH-POWER, HIGH-FREQUENCY LASER SETTINGS FROM MANUFACTURER LASER PRESETS INCREASE THE RISK OF US, WITHOUT IMPROVING SFR. FUTURE STUDIES SHALL FURTHER EVALUATE OPTIMAL LASER SETTINGS DEPENDING ON PATIENT CHARACTERISTICS AND INTRAOPERATIVE SITUATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591646 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Required Intervention