MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS GreenLight XPS; Powered Laser Surgical Instrument

Model Number	0010-0210R
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a foot pedal malfunction as it keeps stuck on one position.No patient involved.
Event or Problem Description
It was reported that there was a foot pedal malfunction as it keeps stuck on one position.No patient involved.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.However, it was serviced onsite by a field service engineer (fse).The reported allegation was confirmed during evaluation.No additional findings were identified.Corrective actions were performed, and the device subsequently underwent functional and safety testing.All test results were satisfactory, and the device was verified to be operating in accordance with manufacturer specifications.The system was confirmed to be fully operational and returned to service.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review of the greenlight xps was completed and confirmed that the event of foot switch pedal stuck in on position was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established; since the reported malfunction could not be confirmed due to a lack of a returned product and insufficient information to determine the most probable cause for the reported issue.

• 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 -201
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive; san jose CA 95134 -201
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25849868
• Report Number: 2124215-2026-38375
• Device Sequence Number: 10582152
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: (01)00878953001906(11)131016(10)XPS50982
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 0010-0210R
• Device Catalogue Number: 0010-0210R
• Device Lot Number: XPS50982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 10/16/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown