BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 22388030 · Received July 2, 2025

    Report

    Report Number
    2124215-2025-39643
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    December 19, 2024
    Report Date
    August 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 12/09/2024, WAS CHOSEN BASED ON YEAR THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE CHEN, P.-H., CHANG, R.-J., WANG, H.-S., CHANG, Y.-H., LIU, C.-Y., HUANG, L.-K., KAN, H.-C., LIN, P.-H., YU, K.-J., CHUANG, C.-K., PANG, S.-T., WU, C.-T., HSIEH, M.-L., & SHAO, I.-H. (2024). IMPACT OF OBESITY ON CLINICAL PRESENTATION AND SURGICAL OUTCOMES IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA RECEIVING GREENLIGHT LASER PROSTATECTOMY. CLINICAL INTERVENTIONS IN AGING, 19, 2071 2083. HTTPS://DOI.ORG/10.2147/CIA.S472579.

    Additional Manufacturer Narrative · 0

    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 COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF THE DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTION FOR USE. BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 12/09/2024, WAS CHOSEN BASED ON YEAR THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE: CHEN, P.-H., CHANG, R.-J., WANG, H.-S., CHANG, Y.-H., LIU, C.-Y., HUANG, L.-K., KAN, H.-C., LIN, P.-H., YU, K.-J., CHUANG, C.-K., PANG, S.-T., WU, C.-T., HSIEH, M.-L., & SHAO, I.-H. (2024). IMPACT OF OBESITY ON CLINICAL PRESENTATION AND SURGICAL OUTCOMES IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA RECEIVING GREENLIGHT LASER PROSTATECTOMY. CLINICAL INTERVENTIONS IN AGING, 19, 2071 2083. HTTPS://DOI.ORG/10.2147/CIA.S472579.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL CLINICAL INTERVENTIONS IN AGING, F THE STUDY WAS TO INVESTIGATE THE IMPACT OF BODY MASS INDEX (BMI) ON PREOPERATIVE CHARACTERISTICS, LOWER URINARY TRACT SYMPTOMS (LUTS), INTRAOPERATIVE VARIABLES, SURGICAL OUTCOMES, AND POSTOPERATIVE COMPLICATIONS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA (BPH) UNDERGOING GREENLIGHT LASER PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP). THE STUDY INCLUDED 843 PATIENTS WHO UNDERWENT GREENLIGHT LASER PVP BETWEEN 2016 AND 2020 AT A SINGLE MEDICAL CENTER IN TAIWAN. COMPLICATIONS WERE CLASSIFIED USING THE CLAVIEN-DINDO SYSTEM, ONLY 75 OUT OF 843 PATIENTS (8.9%), WITH NO SIGNIFICANT DIFFERENCE BETWEEN OBESE AND NON-OBESE GROUPS IT WAS REPORTED GRADE I 44 CASE OF ACUTE URINARY RETENTION AND HEMATURIA; GRADE II 6 CASES OF URINARY TRACT INFECTION, PNEUMONIA; GRADE III 22 CASES BLADDER NECK STRICTURE, PROSTATE ENLARGEMENT REQUIRING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), 3 CASES UROSEPSIS REQUIRING INTENSIVE CARE UNIT (ICU) ADMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL CLINICAL INTERVENTIONS IN AGING, F THE STUDY WAS TO INVESTIGATE THE IMPACT OF BODY MASS INDEX (BMI) ON PREOPERATIVE CHARACTERISTICS, LOWER URINARY TRACT SYMPTOMS (LUTS), INTRAOPERATIVE VARIABLES, SURGICAL OUTCOMES, AND POSTOPERATIVE COMPLICATIONS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA (BPH) UNDERGOING GREENLIGHT LASER PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP). THE STUDY INCLUDED 843 PATIENTS WHO UNDERWENT GREENLIGHT LASER PVP BETWEEN 2016 AND 2020 AT A SINGLE MEDICAL CENTER IN TAIWAN. COMPLICATIONS WERE CLASSIFIED USING THE CLAVIEN-DINDO SYSTEM, ONLY 75 OUT OF 843 PATIENTS (8.9%), WITH NO SIGNIFICANT DIFFERENCE BETWEEN OBESE AND NON-OBESE GROUPS IT WAS REPORTED GRADE I 44 CASE OF ACUTE URINARY RETENTION AND HEMATURIA; GRADE II 6 CASES OF URINARY TRACT INFECTION, PNEUMONIA; GRADE III 22 CASES BLADDER NECK STRICTURE, PROSTATE ENLARGEMENT REQUIRING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), 3 CASES UROSEPSIS REQUIRING INTENSIVE CARE UNIT (ICU) ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164042 UNKNOWN POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION UNK-P-GREENLIGHT CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R