BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 22026653 · Received May 15, 2025

    Report

    Report Number
    2124215-2025-30560
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    March 1, 2023
    Report Date
    May 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATSUMI, A., KURIHARA, Y., TOKUNAGA, M., ET AL. (2025). INITIAL EXPERIENCE WITH TRANSURETHRAL PROSTATE LIFTING AND TRANSURETHRAL WATER VAPOR THERAPY AT NHO OKAYAMA MEDICAL CENTER. 112TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL 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 THE 112TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION THAT THERE WERE (B)(4) CASES OF TRANSURETHRAL WATER VAPOR ENERGY THERAPY (WAVE) PERFORMED FROM (B)(6) 2023 TO (B)(6) 2024. THE MEDIAN AGE OF WAVE WAS 82.5 YEARS, AND THE MEDIAN PROSTATE VOLUME WAS 45.5 ML. THE POSTOPERATIVE COMPLICATIONS INCLUDE (B)(4) CASE OF SCROTUM ABSCESS AND (B)(4) CASES OF URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370446 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other