BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 19702664 · Received July 9, 2024

    Report

    Report Number
    2124215-2024-41945
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    July 1, 2022
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729979135
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KOICHIRO, M., TATSUO, F., MASAYOSHI, K., KO, N., TAKASHI, K., HARUHITO, A. EXPERIENCE OF 100 CASES OF PVP USING 180W GREEN LIGHT XPS FOR BENIGN PROSTATIC HYPERPLASIA AND STUDY OF COMPLICATIONS INCLUDING BLADDER NECK SCLEROSIS. THE 111TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION [PACIFICO YOKOHAMA]. 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 THE 111TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION JOURNAL THAT A STUDY WAS CONDUCTED TO EXAMINE THE EFFECTIVENESS AND SAFETY OF PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE AFTER EXPERIENCING 100 CASES SINCE ITS INTRODUCTION. BETWEEN JULY 2022 TO AUGUST 2023, A TOTAL OF 100 PATIENTS DIAGNOSED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) WERE INCLUDED IN THIS STUDY. FIVE PATIENTS HAD A HISTORY OF URINARY RETENTION, AND FOUR OF THEM HAD AN INDWELLING URINARY CATHETER OR SELF-CATHETERIZED AT THE TIME OF SURGERY. IT WAS OBSERVED THAT THERE WAS POSTOPERATIVE SERUM HEMOGLOBIN CONCENTRATION DECREASE. THERE WERE TWO CASES OF REOPERATION FOR BLADDER NECK SCLEROSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286554 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-0210S-G0 08714729979135

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Other