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

Model Number	0010-0210
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that laser console stopped in the middle of the procedure, and it does not start.This procedure was not completed with a patient under epidural anesthesia.The case was re-scheduled and there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under epidural anesthesia.
Event or Problem Description
It was reported that laser console stopped in the middle of the procedure, and it does not start.This procedure was not completed with a patient under epidural anesthesia.The case was re-scheduled and there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under epidural anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis; however, it was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was found that the resonator was defective and it had to be replaced.Therefore, the reported allegation was confirmed leading to the reported event.The fse proceeded to replace the resonator, perform calibration and finally, the device passed all functional testing.No further issues were identified during service, and the console was confirmed to be fully functional after replacing.Most likely the component damaged could have affected the device performance.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, and a labeling review confirmed the ifu includes appropriate warnings and instructions for use.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 23112490
• Report Number: 2124215-2025-65913
• Device Sequence Number: 9832174
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508(11)100825
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 08/25/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown