BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 22790206 · Received August 12, 2025

    Report

    Report Number
    2124215-2025-54897
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    October 1, 2020
    Report Date
    October 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. CITATION: JOSHUA W., REBECCA K., CASSIDY L., ALIA C., NAEEM B., DEAN E. (2025). QUALITY OF LIFE AND SURGICAL TREATMENT REGRETIN PATIENTS WITH BENIGN PROSTATIC HYPERTROPHY: A MULTICENTER STUDY. CANADIAN JOURNAL OF UROLOGY, 2025; 32 (3):219-227.

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF DYSURIA, BLEEDING, SEXUAL DYSFUNCTION, URINARY FREQUENCY AND MICTURITION URGENCY ARE A KNOWN RISK ASSOCIATED WITH THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. 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. CITATION: JOSHUA W., REBECCA K., CASSIDY L., ALIA C., NAEEM B., DEAN E. (2025). QUALITY OF LIFE AND SURGICAL TREATMENT REGRETTING PATIENTS WITH BENIGN PROSTATIC HYPERTROPHY: A MULTICENTER STUDY. CANADIAN JOURNAL OF UROLOGY, 2025; 32 (3):219-227.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE CANADIAN JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO IDENTIFY PREOPERATIVE IPSS-QOL (INTERNATIONAL PROSTATE SYMPTOM SCORE QUALITY OF LIFE) FOR COMPARISON PURPOSES. A TOTAL OF 54 MALE PATIENTS WITH DIAGNOSIS OF BENIGN PROSTATIC HYPERPLASIA (BPH) WERE ENROLLED FROM OCTOBER 2020 TO MARCH 2023. THE FOLLOWING BOSTON SCIENTIFIC PRODUCTS WERE USED DURING THE PROCEDURES: GREENLIGHT LASER CONSOLE. REGARDING POSTOPERATIVE COMPLICATIONS, THE MOST COMMON REASONS FOR PROCEDURAL REGRET WERE INSUFFICIENT RELIEF OR CONTINUED SYMPTOMS AFTER SURGERY (9 PATIENTS); 2 PATIENTS EXPERIENCED DYSURIA AND IN 2 PATIENTS WERE OBSERVED POST-OPERATIVE BLEEDING. IT WAS ALSO REPORTED THAT 3 PATIENT DEVELOPED ERECTILE DYSFUNCTION AND 2 PATIENTS NEEDED MULTIPLE SURGERIES. SURGICAL TREATMENT FOR BPH GENERALLY LEADS TO IMPROVEMENT IN SYMPTOMS, BUT A SIGNIFICANT SUBSET OF PATIENTS EXPERIENCES DECISIONAL REGRET, PARTICULARLY IN CASES OF PERCEIVED PROCEDURE INEFFICACY OR POSTOPERATIVE COMPLICATIONS. THIS IS CONSISTENT WITH THE OBSERVED CORRELATION BETWEEN INCREASED SYMPTOMATIC IMPROVEMENT AND DECREASED PROCEDURAL REGRET.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE CANADIAN JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO IDENTIFY PREOPERATIVE IPSS-QOL (INTERNATIONAL PROSTATE SYMPTOM SCORE QUALITY OF LIFE) FOR COMPARISON PURPOSES. A TOTAL OF 54 MALE PATIENTS WITH DIAGNOSIS OF BENIGN PROSTATIC HYPERPLASIA (BPH) WERE ENROLLED FROM OCTOBER 2020 TO MARCH 2023. THE FOLLOWING BOSTON SCIENTIFIC PRODUCTS WERE USED DURING THE PROCEDURES: GREENLIGHT LASER CONSOLE. REGARDING POSTOPERATIVE COMPLICATIONS, THE MOST COMMON REASONS FOR PROCEDURAL REGRET WERE INSUFFICIENT RELIEF OR CONTINUED SYMPTOMS AFTER SURGERY (9 PATIENTS); 2 PATIENTS EXPERIENCED DYSURIA AND IN 2 PATIENTS WERE OBSERVED POST-OPERATIVE BLEEDING. IT WAS ALSO REPORTED THAT 3 PATIENT DEVELOPED ERECTILE DYSFUNCTION AND 2 PATIENTS NEEDED MULTIPLE SURGERIES. SURGICAL TREATMENT FOR BPH GENERALLY LEADS TO IMPROVEMENT IN SYMPTOMS, BUT A SIGNIFICANT SUBSET OF PATIENTS EXPERIENCES DECISIONAL REGRET, PARTICULARLY IN CASES OF PERCEIVED PROCEDURE INEFFICACY OR POSTOPERATIVE COMPLICATIONS. THIS IS CONSISTENT WITH THE OBSERVED CORRELATION BETWEEN INCREASED SYMPTOMATIC IMPROVEMENT AND DECREASED PROCEDURAL REGRET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79512 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention