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

Model Number	0010-0210S-G0
Medical Device Problem Codes	No Display/Image (1183); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the laser was powered on, the display screen was black and burning smell was coming out of laser.Another device of different model was used to complete the procedure.There was no patient complication.
Additional Manufacturer Narrative
The console was not returned for analysis; however, it was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, there was found that the chiller was defective and had to be replaced.Therefore, the reported allegation was confirmed leading to the reported event.After the chiller was replaced, the issue was resolved.Most likely the component damaged could have affected the device performance.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, and a labeling review confirmed the ifu includes appropriate warnings and instructions for use.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure when the laser was powered on, the display screen was black and burning smell was coming out of laser.Another device of different model was used to complete the procedure.There was no patient complication.
Additional Manufacturer Narrative
Initially, this device was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, there was found a number of damaged components.The vsb (auto voltage select board), resonator, pdb (power distribution board, q-switch, chiller and top cover were replaced but it did not correct the issues.Therefore, the reported allegation of no display or display failure and smoking was confirmed leading to the reported event.Most likely there was an electrical short that fired several circuits.This would produce the smoke seen and then kill the system so the display would not turn on.Therefore, it concluded that an electrical fault was the most probable cause of the complaint.According to the device history record review, this device was installed on 10/24/2022.The system was last serviced on 2/4/2025.The console was fully functional with no issues from that time.This laser console was installed on 24 october 2022, and it was covered under a semi-annual pm service contract.The system was last serviced on 04 february 2025.The laser console was fully functional with no issues from that time until the reported event date of (b)(6) 2025.Regarding the device instructions for use (ifu), it did not reveal any evidence of device off-label use or failure to follow instructions.The ifu includes appropriate warnings and instructions for use.There was no evidence that the console was used in a manner inconsistent with the labeling as per xps greenlight operator manual.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure when the laser was powered on, the display screen was black and burning smell was coming out of laser.Another device of different model was used to complete the procedure.There was no patient complication.

• 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: 23110948
• Report Number: 2124215-2025-65908
• Device Sequence Number: 21304502
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: (01)08714729979135(10)XPS61209
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/28/2026

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: XPS61209
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 04/06/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/13/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male