BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 24202450 · Received January 28, 2026

    Report

    Report Number
    2124215-2026-05093
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    January 1, 2023
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. KLEIN, C., ANRACT, J., PINAR, U., CHEVROT, A., DELLA NEGRA, E., FASSI-FEHRI, H., GAS, J., ROUSCOFF, Y., WILISCH, J., SARAZIN, C., DOIZI, S., & LEBDAI, S. (2025). SURGICAL AND INTERVENTIONAL MANAGEMENT OF BLADDER OUTLET OBSTRUCTION RELATED TO BENIGN PROSTATIC HYPERPLASIA: SYSTEMATIC REVIEW OF THE LITERATURE AND CLINICAL PRACTICE GUIDELINES FROM THE FRENCH MALE LUTS COMMITTEE (CTMH). THE FRENCH JOURNAL OF UROLOGY, 35(11), 102951. HTTPS://DOI.ORG/10.1016/J.FJUROL.2025.102951.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE FRENCH JOURNAL OF UROLOGY THAT A SYSTEMATIC REVIEW WAS CONDUCTED TO UPDATE THE FRENCH RECOMMENDATIONS PUBLISHED IN 2021, AS WELL AS THE 2024 EUROPEAN ASSOCIATION OF UROLOGY GUIDELINES, ON THE SURGICAL AND INTERVENTIONAL MANAGEMENT OF BLADDER OUTLET OBSTRUCTION RELATED TO BENIGN PROSTATIC HYPERPLASIA. THE REVIEW OF THE LITERATURE WAS PERFORMED THROUGH PUBMED FROM 2023-2025, COMPLEMENTING THE DATA ALREADY INCLUDED IN PREVIOUS GUIDELINES. THIS PROCESS WAS BASED ON A PREDEFINED BIBLIOGRAPHIC STRATEGY, FOLLOWED BY A CRITICAL ANALYZE OF THE PUBLICATIONS WITH ASSIGNMENT OF LEVELS OF EVIDENCE, FORMULATION OF CONCLUSIONS, AND DEVELOPMENT OF RECOMMENDATIONS ADDRESSING SPECIFIC CLINICAL QUESTIONS. FOR PROSTATE PHOTO VAPORIZATION PROCEDURES (PVP) PERFORMED WITH GREENLIGHT LASER SYSTEMS, SOME PATIENTS EXPERIENCED ADVERSE EVENTS SUCH AS URINARY INCONTINENCE, STRESS INCONTINENCE, URINARY URGENCY, CLOT RETENTION AND SEXUAL DYSFUNCTION. SOME PATIENTS REQUIRED RETREATMENT AND BLOOD TRANSFUSION. GREENLIGHT PVP IS AN ALTERNATIVE TO TURP FOR SURGICAL TREATMENT OF PATIENTS WITH MODERATE-TO-SEVERE LOWER URINARY TRACT SYMPTOMS AND PROSTATE VOLUMES BETWEEN 30 AND 80 CM3. GREENLIGHT PVP SHOULD BE OFFERED FOR PATIENTS AT INCREASED RISK OF BLEEDING. BIPOLAR VAPORIZATION IS AN ALTERNATIVE TO TURP FOR SURGICAL TREATMENT OF PATIENTS WITH MODERATE-TO-SEVERE LOWER URINARY TRACT SYMPTOMS AND PROSTATE VOLUMES BETWEEN 30 AND 80 CM3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85314 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention