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

Model Number	0010-0210R
Medical Device Problem Codes	Insufficient Cooling (1130); Communication or Transmission Problem (2896); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the device displayed error codes 641 (chiller serial not set), 302-13 (fiber not present) and 202-11 (interlock open).The device was unable to be used for the procedure and the procedure was stopped.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or whose sedation status is 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 -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: 50915299
• Report Number: 2124215-2026-51392
• Device Sequence Number: 5330462
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: XPS50895
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 07/18/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown