BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 23075231 · Received September 17, 2025

    Report

    Report Number
    2124215-2025-64938
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    July 17, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMIR M, MAHMOUD MA, ABDELMONEM HA, ELREFAIE M, GAD KA. A COMPARATIVE ANALYSIS OF THE OUTCOMES OF REZUM THERAPY BASED ON PROSTATE SIZE: A FOUR-YEAR RETROSPECTIVE ANALYSIS. WORLD J UROL. 2025 JUL 17;43(1):443. DOI: 10.1007/S00345-025-05793-0. PMID: 40676194; PMCID: PMC12271246. B3. ACTUAL EVENT DATE WAS UNKNOWN. THE ARTICLE PUBLISHED DATE WAS SELECTED.

    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 ARE A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AS INDICATED IN THE INSTRUCTIONS FOR USE. SAMIR M, MAHMOUD MA, ABDELMONEM HA, ELREFAIE M, GAD KA. A COMPARATIVE ANALYSIS OF THE OUTCOMES OF REZUM THERAPY BASED ON PROSTATE SIZE: A FOUR-YEAR RETROSPECTIVE ANALYSIS. WORLD J UROL. 2025 JUL 17;43(1):443. DOI: 10.1007/S00345-025-05793-0. PMID: 40676194; PMCID: PMC12271246. B3. ACTUAL EVENT DATE WAS UNKNOWN. THE ARTICLE PUBLISHED DATE WAS SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A FOUR-YEAR RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFICACY OF REZUM THERAPY IN PATIENTS WITH SMALL (<80 G) AND LARGE (80-120 G) PROSTATES. THE STUDY INCLUDED 170 PATIENTS, EQUALLY DIVIDED INTO TWO GROUPS, AND PROCEDURES WERE PERFORMED BY THE SAME SURGICAL TEAM BETWEEN JANUARY 2021 AND JANUARY 2025. PATIENTS WERE FOLLOWED AT 3, 12, 24, 36, AND 48 MONTHS FOR QMAX, IPSS, PVR, PSA, QOL, IIEF, PROSTATE SIZE, AND POSTOPERATIVE COMPLICATIONS. RESULTS SHOWED SIGNIFICANT IMPROVEMENT IN URINARY AND QUALITY-OF-LIFE OUTCOMES FOR BOTH GROUPS, WITH OPERATIVE TIME, NUMBER OF INJECTIONS, AND CATHETER DURATION HIGHER IN THE LARGE PROSTATE GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED HEMATURIA, DYSURIA, URINARY TRACT INFECTION, URINARY RETENTION, RETROGRADE EJACULATION, URGENCY, INCONTINENCE, AND HEMATOSPERMIA; THE RATES WERE SIMILAR BETWEEN GROUPS. HOWEVER, THE NEED FOR RETREATMENT WAS SIGNIFICANTLY HIGHER IN THE LARGE PROSTATE GROUP (15.3%) COMPARED WITH THE SMALL PROSTATE GROUP (2.4%). RETREATMENT STRATEGIES INCLUDED MEDICAL THERAPY WITH ALPHA-BLOCKERS, REPEAT REZUM, OR B-TURP AS INDICATED. NO ADDITIONAL LONG-TERM SAFETY CONCERNS WERE REPORTED, AND REZUM THERAPY WAS CONCLUDED TO BE SAFE AND EFFECTIVE ACROSS PROSTATE SIZES, WITH HIGHER RETREATMENT RATES IN LARGER GLANDS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A FOUR-YEAR RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFICACY OF REZUM THERAPY IN PATIENTS WITH SMALL (<80 G) AND LARGE (80-120 G) PROSTATES. THE STUDY INCLUDED 170 PATIENTS, EQUALLY DIVIDED INTO TWO GROUPS, AND PROCEDURES WERE PERFORMED BY THE SAME SURGICAL TEAM BETWEEN JANUARY 2021 AND JANUARY 2025. PATIENTS WERE FOLLOWED AT 3, 12, 24, 36, AND 48 MONTHS FOR QMAX, IPSS, PVR, PSA, QOL, IIEF, PROSTATE SIZE, AND POSTOPERATIVE COMPLICATIONS. RESULTS SHOWED SIGNIFICANT IMPROVEMENT IN URINARY AND QUALITY-OF-LIFE OUTCOMES FOR BOTH GROUPS, WITH OPERATIVE TIME, NUMBER OF INJECTIONS, AND CATHETER DURATION HIGHER IN THE LARGE PROSTATE GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED HEMATURIA, DYSURIA, URINARY TRACT INFECTION, URINARY RETENTION, RETROGRADE EJACULATION, URGENCY, INCONTINENCE, AND HEMATOSPERMIA; THE RATES WERE SIMILAR BETWEEN GROUPS. HOWEVER, THE NEED FOR RETREATMENT WAS SIGNIFICANTLY HIGHER IN THE LARGE PROSTATE GROUP (15.3%) COMPARED WITH THE SMALL PROSTATE GROUP (2.4%). RETREATMENT STRATEGIES INCLUDED MEDICAL THERAPY WITH ALPHA-BLOCKERS, REPEAT REZUM, OR B-TURP AS INDICATED. NO ADDITIONAL LONG-TERM SAFETY CONCERNS WERE REPORTED, AND REZUM THERAPY WAS CONCLUDED TO BE SAFE AND EFFECTIVE ACROSS PROSTATE SIZES, WITH HIGHER RETREATMENT RATES IN LARGER GLANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553353 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other