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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device does not start up, and errors 630, 302.13, 202.11 and 710 displayed.The errors cleared, but error 630 showed again.The console was restarted after refilling purified water, but the problem persisted.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that the device does not start up, and errors 630, 302.13, 202.11 and 710 displayed.The errors cleared, but error 630 showed again.The console was restarted after refilling purified water, but the problem persisted.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported errors were confirmed.The fse cleared the errors, and only error 630 remained.The distilled water was replenished, and the console was restarted, but the error persisted.The fse performed flow switch replacement and conducted laser output test and calibration, restoring the console's functionality.Based on fse evaluation, it is likely that the flow switch was not working as expected, contributing to the console difficulties encountered which led to the procedure being aborted.
Event or Problem Description
It was reported that the device does not start up, and errors 630, 302.13, 202.11 and 710 displayed.The errors cleared, but error 630 showed again.The console was restarted after refilling purified water, but the problem persisted.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
Correction to field d4: unique identifier (udi) #.The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported errors were confirmed.The fse cleared the errors, and only error 630 remained.The distilled water was replenished, and the console was restarted, but the error persisted.The fse performed flow switch replacement and conducted laser output test and calibration, restoring the console's functionality.Based on fse evaluation, it is likely that the flow switch was not working as expected, contributing to the console difficulties encountered which led to the procedure being aborted.

• 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: 21458199
• Report Number: 2124215-2025-11117
• Device Sequence Number: 12740820
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: (01)08714729979135(10)XPS62007(21)XPS62007
• 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,Followup,Followup
• Report Date (Section B): 04/04/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 04/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/04/2025
• Date Device Manufactured: 05/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown