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

Model Number	0010-0210Z
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the photovaporization of the prostate procedure, errors 171 and 820 displayed.Due to this, the procedure could not be completed.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 during the photovaporization of the prostate procedure, errors 171 and 820 displayed.Due to this, the procedure could not be completed.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.

• 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): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive; san jose CA 95134 2011
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21802368
• Report Number: 2124215-2025-21503
• Device Sequence Number: 9251066
• Product Code: GEX
• UDI-Device Identifier: 00878953001913
• UDI-Public: (01)00878953001913(10)XPS60471
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 06/03/2025

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: 0010-0210Z
• Device Catalogue Number: 0010-0210Z
• Device Lot Number: XPS60471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 02/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown