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

Model Number	0010-0210S-G0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, the console did not proceed from please wait, therefore, the device could not be used.There were no patient complications, however, the procedure was not completed due to reported issue.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Event or Problem Description
It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, the console did not proceed from please wait, therefore, the device could not be used.There were no patient complications, however, the procedure was not completed due to reported issue.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and found that the top cover (previously replaced with a replacement part) was exchanged for a new one.Following the replacement, the console worked fine.A functional test was conducted using a checklist, confirming that the power pins were intact, rf output and cooling water flow rate were within expected parameters, and laser output was properly adjusted.A general operational check revealed no abnormalities.Additionally, an investigation of the top cover included a visual inspection and a functional test, both of which passed successfully.Two components were returned and analyzed.Functional testing was performed using the gold unit test and the firmware and hardware were confirmed to be up to date.The card reader and touchscreen operated as intended, and the display showed no problems.Both returned units, successfully passed functional testing.Additionally, the reported issue of a please wait message was not observed during the investigation, therefore, the reported event was not confirmed.Based on analysis and the information available, a conclusion code of no problem detected was assigned to this investigation.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21646740
• Report Number: 2124215-2025-16660
• Device Sequence Number: 20736683
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: (01)08714729979135(10)XPS62043(21)XPS62043
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: XPS62043
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown