MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS GREENLIGHT XPS; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-0210
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, there was a clicking noise during treatment.The procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
D4 unique identifier (udi) #: corrected.With all the available information, boston scientific concludes that the reported clicking sound event was confirmed.During service of the console at the customer site, the top cover was replaced, however, the issue was not resolved.Then, the laser power supply (lps) and the master control board (mcb) were replaced, which resolved the issue.The console was calibrated and passed the full functional and electrical safety testing performed.Furthermore, the mcb was returned for analysis for visual inspection, and it passed the inspection.The lps was also returned for analysis for visual inspection and functional testing, and it passed both testing.Based on analysis results and information available, most likely an electrical issue related to the mcb caused the reported clicking sound.
Event or Problem Description
It was reported that, there was a clicking noise during treatment.The procedure was not completed due to this event.There were no patient complications.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): AMERICAN MEDICAL SYSTEMS; innovation ctr, silicon valley; 3070 orchard drive; san jose CA 95134 2011
• 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: 21463331
• Report Number: 2124215-2025-10919
• Device Sequence Number: 8749730
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508(11)160801(21)XPS50835
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 0010-0210
• Device Catalogue Number: 0010-0210
• Device Lot Number: OEMTRACE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown