BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 22377619 · Received July 1, 2025

    Report

    Report Number
    2124215-2025-42978
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 31, 2023
    Report Date
    July 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KIN, C. W., TING, K. L., SIU, K. L., NING, H. C., CHEUK, M. L., KA, W. W. (2023). DAY SURGERY IN THE TREATMENT OF BENIGN PROSTATIC OBSTRUCTION WITH PHOTOSELECTIVE VAPORISATION OF THE PROSTATE: A SINGLE INSTITUTION EXPERIENCE. SURGICAL PRACTICE, 28, PAGES 11-15. DOI: 10.1111/1744-1633.12672 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 UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. B3. DATE OF EVENT: EXACT EVENT DATE IS UNKNOWN. DATE PUBLISHED WAS USED. 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 USE OF 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN SURGICAL PRACTICE JOURNAL THAT A PROSPECTIVE STUDY WAS CONDUCTED IN ORDER TO ASSESS THE FEASIBILITY, EFFICACY AND SAFETY OF PERFORMING PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) AS A DAY-SURGERY PROCEDURE FOR PATIENTS WITH BENIGN PROSTATIC OBSTRUCTION. THE STUDY OCCURRED WITH 37 MEN FROM FEBRUARY 2017 TO MARCH 2021 WITH A GREENLIGHT XP LASER AND SIDE FIRING MOXY FIBERS. POSTOPERATIVE COMPLICATIONS INCLUDED HEMATURIA, URINARY TRACT INFECTION, HEMORRHAGE, UROSEPSIS, RETROGRADE EJACULATION, INCONTINENCE, ERECTILE DYSFUNCTION, BLEEDING, BLEEDING REQUIRING INTERVENTION, INFECTION, RETENTION. ONE PATIENT HAD FEVER AND DYSURIA DUE TO SEPTIC SHOCK. HE WAS READMITTED AND TREATED WITH INTRAVENOUS FLUID, ANTIBIOTICS. ONE PATIENT WAS READMITTED FOR SECONDARY HEMORRHAGE REQUIRING CAUTERIZATION AT THE BLADDER NECK. TWO PATIENTS REQUIRED A SECOND SURGERY ATTEMPT WHICH WERE SUCCESSFUL. TWO PATIENTS HAD URINE RETENTION AND WERE TREATED WITH A FOLEY CATHETER. THEY WERE ABLE TO WEAN OFF A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382348 UNKNOWN POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION UNK-P-GREENLIGHT FIBER

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other GREENLIGHT XP LASER