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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Smoking (1585); Power Problem (3010); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console shutdown and the error codes 210-laser power supply and 211-laser power supply brick fault were displayed.After shutting down, it did not start even when the power was turned back on.When the power cord was unplugged and left for a while before restarting, smoke was emitted, possibly due to something burning inside.The procedure was completed with turp (transurethral resection of the prostate) without patient complications.
Event or Problem Description
It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, the console shutdown and the error codes 210-laser power supply and 211-laser power supply brick fault were displayed.After shutting down, it did not start even when the power was turned back on.When the power cord was unplugged and left for a while before restarting, smoke was emitted, possibly due to something burning inside.The procedure was completed with turp (transurethral resection of the prostate) without patient complications.
Additional Manufacturer Narrative
B5.Describe event or problem updated.E1.Initial reporter information updated.
Additional Manufacturer Narrative
The console was serviced onsite by a field service engineer (fse) and was found that the auto voltage select board (vsb) and laser power supply (lps) were damaged, therefore, replaced.The reported allegations were due to an electrical failure.The smoking report was due to a component fired that lead to the smoking.The console was also returned for analysis, and it passed visual inspection.However, it failed to power on and failed the grange test station due to the vsb damaged.After both components were replaced, the problem was resolved, thus, confirming the reported event.The reported device performance allegation cannot be confirmed.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.The instructions for use (ifu) were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.A risk review was completed and confirmed that the event of smoking is defined in the risk documentation.Based on the analysis results, the investigation is assigned a conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, the console shutdown and the error codes 210-laser power supply and 211-laser power supply brick fault were displayed.After shutting down, it did not start even when the power was turned back on.When the power cord was unplugged and left for a while before restarting, smoke was emitted, possibly due to something burning inside.The procedure was completed with turp (transurethral resection of the prostate) without patient complications.

• Brand Name: GREENLIGHT XPS?
• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23791133
• Report Number: 2124215-2025-90624
• Device Sequence Number: 5712313
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: (01)08714729979135(10)XPS61207
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0010-0210S-G0
• Device Catalogue Number: 0010-0210S-G0
• Device Lot Number: XPS61207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 03/27/2026; 05/11/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/29/2025; 04/17/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown