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

Model Number	0010-0210R
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Integrity Problem (2978); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the device displayed error codes 831 (interlock during warmup), 302.13 (mcb hardware interlock bit), 102.9 (rcb hardware interlock bit), and 235 (no lps current).The procedure was canceled.There was no patient impact, as the procedure had not been initiated.This event is being reported for an aborted/cancelled procedure with a patient under unknown sedation.

• 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: 25767012
• Report Number: 2124215-2026-36874
• Device Sequence Number: 9741036
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup,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: XPS50819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: 08/07/2026; 09/21/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 08/11/2026; 09/29/2026
• Date Device Manufactured: 05/03/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male