BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSES PULSE

    MDR report key: 25326317 · Received May 28, 2026

    Report

    Report Number
    2124215-2026-28843
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 8, 2025
    Report Date
    May 28, 2026
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VERGAMINI, B. L., WHILES, B. B., MCMAHON, A., CRESWELL, M., STARKEY, J., SMITH, J., SARDIU, M. E., NEFF, D. A., DUCHENE, D. A., MOLINA, W. R. (2025). VACUUM-ASSISTED RENAL SHEATH CLEARS 1 CM3 OF STONE FASTER THAN NON-SUCTION SHEATH IN MINI-PERCUTANEOUS NEPHROLITHOTOMY. WORLD JOURNAL OF UROLOGY, 43 (284). HTTPS://DOI.ORG/10.1007/S00345-025-05629-X. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY, THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO COMPARE THE SURGICAL OUTCOMES OF MINI-PERCUTANEOUS NEPHROLITHOTOMY (MINI-PCNL) TO CLEAR RENAL STONES, USING A VACUUM-ASSISTED RENAL ACCESS SHEATH (VA-RAS) VERSUS AN USUAL MINIATURIZED RENAL ACCESS SHEATH (RAS). BETWEEN AUGUST 2021 AND JULY 2024, 111 PATIENTS UNDERWENT MINI-PCNL AT ONE INSTITUTION IN THE UNITED STATES. 57 PATIENTS HAD THE VA-RAS, AND 54 PATIENTS HAD THE MINIATURIZED RAS. ONCE ACCESS WAS ACHIEVED USING EITHER SHEATH, ALL PATIENTS UNDERWENT THE NEPHROLITHOTRIPSY PROCEDURE USING A LUMENIS PULSE P120H CONSOLE. FOLLOWING PROCEDURE, 102 PATIENTS HAD A POSTOPERATIVE STENT, 14 PATIENTS HAD A POSTOPERATIVE NEPHROSTOMY, 2 PATIENTS FROM THE RAS GROUP HAD A URETERAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432685 MOSES PULSE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-P120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention