BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPULSE POWERSUITE

    MDR report key: 25303089 · Received May 27, 2026

    Report

    Report Number
    2124215-2026-28390
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    September 30, 2025
    Report Date
    May 27, 2026
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PASSARELLI, F., BASADONNA, L. M., CIAMARRA, F., BONACINA, E., GRAPS, G., SORBA, E., PAROLIN, V., LUCIGNANI, G., RIPA, F., ZANETTI, S. P., LONGO, F., DE LORENZIS, E., ALBO, G., MONTANARI, E., & BOERI, L. (2026). ACUTE KIDNEY INJURY FOLLOWING MINI PERCUTANEOUS NEPHROLITHOTOMY FOR RENAL STONES: PREDICTORS AND FOLLOW-UP EVALUATION IN REAL-LIFE SETTING. INTERNATIONAL BRAZ J UROL : OFFICIAL JOURNAL OF THE BRAZILIAN SOCIETY OF UROLOGY, 52(1), E20250453. HTTPS://DOI.ORG/10.1590/S1677-5538.IBJU.2025.0453

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE INTERNATIONAL BRAZILIAN JOURNAL OF UROLOGY THAT A RETROSPECTIVE STUDY CONDUCTED BETWEEN JANUARY 2016 AND OCTOBER 2024 AT A SINGLE TERTIARY ACADEMIC CENTER EVALUATED THE PREVALENCE, PREDICTORS, AND PROGRESSION OF ACUTE KIDNEY INJURY (AKI) IN PATIENTS WHO UNDERWENT MINI-PERCUTANEOUS NEPHROLITHOTOMY (MPCNL) FOR RENAL STONES. A TOTAL OF 569 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS, WITH A MEDIAN AGE OF 57 YEARS. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA BY EXPERIENCED ENDOUROLOGISTS USING EITHER A 16 F CLEARPETRA SET FOR VACUUM-ASSISTED MPCNL OR A MIP 16 F METALLIC SHEATH FOR VACUUM-CLEANER MPCNL, IN COMBINATION WITH A 12 F MIP NEPHROSCOPE AND A HOLMIUM LASER, VERSAPULSE POWERSUITE 100 W BY LUMENIS, WITH STONE FRAGMENTATION PERFORMED USING A 550 HOLMIUM:YAG LASER FIBER. REGARDING POSTOPERATIVE OUTCOMES, ACUTE KIDNEY INJURY OCCURRED IN 40 PATIENTS (7.0%). OVERALL POSTOPERATIVE COMPLICATIONS OCCURRED IN 138 PATIENTS (24.2%), INCLUDING CLAVIEN-DINDO GRADE I-II COMPLICATIONS IN 118 PATIENTS (20.7%) AND CLAVIEN-DINDO GRADE IIIA/IIIB COMPLICATIONS IN 20 PATIENTS (3.5%). AMONG THE 40 PATIENTS WHO DEVELOPED AKI, 9 PATIENTS (22.5%) HAD PERSISTENT AKI AT FOLLOW-UP. THE STUDY CONCLUDED THAT AKI REMAINS A CLINICALLY SIGNIFICANT COMPLICATION FOLLOWING MPCNL, WITH WORSE BASELINE RENAL FUNCTION, PROLONGED OPERATIVE TIME, HIGHER BODY MASS INDEX (BMI), AND POSTOPERATIVE COMPLICATIONS IDENTIFIED AS RELEVANT PREDICTORS OF AKI OR DELAYED RENAL RECOVERY. NO DEVICE MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359929 VERSAPULSE POWERSUITE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-VPPS_SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Other