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

Model Number	0010-0210S-GZ0
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Power Up (1476); Power Problem (3010); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the console displayed error code 213 (laser power supply off setpoint) after 30 minutes of use.When "clear problem" was pressed, the power shut off and the console would not start up afterward.Restarting from the breaker did not change the situation.There was a slight unusual odor was also noted.The procedure was complete using a non bsc product.There were no patient complications.A field service engineer (fse) was dispatched and serviced the console at the facility.During evaluation of the console, a burning smell was detected; therefore, reportability criteria is met based on this finding.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console was inspected and it was found that there was a burnt smell coming from the console.It was identified that the voltage selection board (vsb) was burn and there was an electrical fault with the laser power supply (lps).The vsb and lps were replaced and the console was calibrated.After replacing the vsb and lsp the issue was resolved, as result, the console was within specification and functioning as intended.In addition, the vsb and lps were returned to our post market quality assurance laboratory for analysis.Visual inspection identified that the lps was in good condition, however, the vsb presente a blown capacitor and burn marks on the board.Also, functional testing identified that the lps would not power on.Service history record review was performed, and it was identified that this console was installed on (b)(6) 2025.The console was last serviced on (b)(6) 2025.The console was fully functional until the reported event date of (b)(6) 2025.A review of the device instructions for use (ifu) was completed, there were no issues with the translation, wording or graphics.There was no evidence that the device was not used in accordance with the ifu.A risk review was completed and confirmed that the event of device displays 213 lps off setpoint, unexpected shutdown and failure to power-up were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on investigation findings, an investigation conclusion code of cause traced to component failure was assigned to this investigation.Based on all information available, due to the identified burnt smell encountered during repair services of the console this event meets reporting criteria.

• 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: 24974810
• Report Number: 2124215-2026-22244
• Device Sequence Number: 4954863
• Product Code: GEX
• UDI-Device Identifier: 08714729979173
• UDI-Public: (01)08714729979173(10)XPS61205
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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-GZ0
• Device Catalogue Number: 0010-0210S-GZ0
• Device Lot Number: XPS61205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown