BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE

    MDR report key: 25333482 · Received May 29, 2026

    Report

    Report Number
    2124215-2026-28845
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    September 11, 2024
    Report Date
    May 29, 2026
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GU, Z. B., QIU, L., ZHU, H., LU, M., AND CHEN, J. G. (2024). THROMBOELASTOGRAPHY IN LONG-TERM ANTIPLATELET THERAPY FOR PATIENTS DIAGNOSED WITH BENIGN PROSTATE HYPERPLASIA UNDERGOING HOLMIUM LASER ENUCLEATION OF THE PROSTATE: A RETROSPECTIVE STUDY. THERAPEUTICS AND CLINICAL RISK MANAGEMENT, 20, 633-639. HTTPS://DOI.ORG/10.2147/TCRM.S472153. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. 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 THERAPEUTICS AND CLINICAL RISK MANAGEMENT THAT A RETROSPECTIVE SINGLE-CENTER STUDY CONDUCTED AT THE AFFILIATED HOSPITAL 2 OF NANTONG UNIVERSITY IN CHINA EVALUATED THE SAFETY AND EFFICACY OF LOW-POWER VERSUS HIGH-POWER HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA (BPH) RECEIVING CONTINUOUS ANTIPLATELET THERAPY. THE STUDY REVIEWED PROCEDURES PERFORMED BETWEEN MARCH 2019 AND MARCH 2022 AND INCLUDED 210 PATIENTS WITH MEDIUM-SIZED PROSTATES. THE PROCEDURES UTILIZED A 120 W VERSAPULSE POWERSUITE HOLMIUM:YAG LASER SYSTEM AND A 550 SLIMLINE LASER FIBER MANUFACTURED BY LUMENIS LTD. REPORTED POSTOPERATIVE COMPLICATIONS INCLUDED URINARY RETENTION, STRESS URINARY INCONTINENCE (SUI), BLADDER SPASM, CAPSULAR PERFORATION, URINARY TRACT INFECTION, BLOOD TRANSFUSION, URETHRAL STRICTURE, AND HEMATURIA. THE STUDY CONCLUDED THAT LOW-POWER HOLEP REDUCED ENUCLEATION AND MORCELLATION TIMES, BLADDER IRRIGATION DURATION, POSTOPERATIVE CATHETERIZATION DURATION, HOSPITAL STAY, AND HEMOGLOBIN DROP COMPARED TO HIGH-POWER HOLEP, WHILE REMAINING FEASIBLE IN PATIENTS RECEIVING CONTINUOUS ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440522 SLIMLINE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-SLIMLINE_FIBERS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H