MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT HPS; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-2090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: the exact date of the event is unknown.The provided event date, 11/01/2011, was chosen as the best estimate based on the first date mentioned in the article.D4: detailed product information was not provided to bsc.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.
Event or Problem Description
It was reported to boston scientific via a poster presented at the 112th annual meeting of the japanese urological association that a retrospective analysis was conducted on 929 patients who underwent photoselective vaporization of the prostate (pvp) for benign prostatic hyperplasia (bph) between november 2011 and march 2024 to identify reoperation rates, types of surgeries, and risk factors for reoperation during long-term follow-up.The median patient age was 73 years, with a median preoperative psa of 4.0 ml/dl and a median prostate volume of 50 ml.The median follow-up period was 923 days.The overall reoperation rate was 10.1%, with various types of reoperations including transurethral hemostasis, pvp for prostatic hyperplasia, turp, urethral dilation for bladder neck sclerosis, and transurethral cystolithotripsy for bladder stones.One percent of patients underwent radical prostatectomy due to a subsequent diagnosis of prostate cancer.No significant differences in age, psa, energy, prostate volume, or surgery time were found between the reoperation and non-reoperation groups, although a longer follow-up period was associated with a higher likelihood of reoperation for prostatic hyperplasia.
Additional Manufacturer Narrative
B3: the exact date of the event is unknown.The provided event date, 11/01/2011, was chosen as the best estimate based on the first date mentioned in the article.D4: detailed product information was not provided to bsc.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.Hayata, n., watanabe, t., miura, t., arakaki, r., mishina, m., & kanno, t.(2025, april).Retrospective study of reoperation in long-term follow-up after photoselective vaporization of the prostate (pvp) for benign prostatic hyperplasia (bph) [conference poster].The 112th annual meeting of the japanese urological association, fukuoka, japan.
Event or Problem Description
It was reported to boston scientific via a poster presented at the 112th annual meeting of the japanese urological association that a retrospective analysis was conducted on 929 patients who underwent photoselective vaporization of the prostate (pvp) for benign prostatic hyperplasia (bph) between november 2011 and march 2024 to identify reoperation rates, types of surgeries, and risk factors for reoperation during long-term follow-up.The median patient age was 73 years, with a median preoperative psa of 4.0 ml/dl and a median prostate volume of 50 ml.The median follow-up period was 923 days.The overall reoperation rate was 10.1%, with various types of reoperations including transurethral hemostasis, pvp for prostatic hyperplasia, turp, urethral dilation for bladder neck sclerosis, and transurethral cystolithotripsy for bladder stones.One percent of patients underwent radical prostatectomy due to a subsequent diagnosis of prostate cancer.No significant differences in age, psa, energy, prostate volume, or surgery time were found between the reoperation and non-reoperation groups, although a longer follow-up period was associated with a higher likelihood of reoperation for prostatic hyperplasia.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.A dhr and ship history review cannot be performed as the lot number and facility account number were not available.The instructions for use (ifu) were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.The symptoms experienced by the patient are listed in the ifu warning of potential outcomes.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.Correction to field h11.Additional mfr narrative b3: the exact date of the event is unknown.The provided event date, 11/01/2011, was chosen as the best estimate based on the first date mentioned in the article.D4: detailed product information was not provided to bsc.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.Hayata, n., watanabe, t., miura, t., arakaki, r., mishina, m., & kanno, t.(2025, april).Retrospective study of reoperation in long-term follow-up after photoselective vaporization of the prostate (pvp) for benign prostatic hyperplasia (bph) [conference poster].The 112th annual meeting of the japanese urological association, fukuoka, japan.
Event or Problem Description
It was reported to boston scientific via a poster presented at the 112th annual meeting of the japanese urological association that a retrospective analysis was conducted on 929 patients who underwent photoselective vaporization of the prostate (pvp) for benign prostatic hyperplasia (bph) between (b)(6) 2011 and (b)(6) 2024 to identify reoperation rates, types of surgeries, and risk factors for reoperation during long-term follow-up.The median patient age was 73 years; with a median preoperative psa of 4.0 ml/dl and a median prostate volume of 50 ml.The median follow-up period was 923 days.The overall reoperation rate was 10.1%, with various types of reoperations including transurethral hemostasis, pvp for prostatic hyperplasia, turp, urethral dilation for bladder neck sclerosis, and transurethral cystolithotripsy for bladder stones.One percent of patients underwent radical prostatectomy due to a subsequent diagnosis of prostate cancer.No significant differences in age, psa, energy, prostate volume, or surgery time were found between the reoperation and non-reoperation groups, although a longer follow-up period was associated with a higher likelihood of reoperation for prostatic hyperplasia.

• Brand Name: GREENLIGHT HPS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; taman perindustrial batu kawan; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22030712
• Report Number: 2124215-2025-30606
• Device Sequence Number: 18182811
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: (01)00878953004709
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 11/05/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/25/2025; 11/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown