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

Model Number	0010-0210
Medical Device Problem Codes	Power Conditioning Problem (1474); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the laser shut off twice in the middle of a case.It was found the breaker was tripped, it was repaired, the breaker was on, but it powered down again.The procedure was not completed due to the power issue.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The product was not returned for analysis; however, the complaint could be confirmed according to work performed by a field service engineer (fse) at the customer site.The fse performed a functional test and did not find fault conditions during testing.The device history record (dhr) met all material, assembly and performance specifications.The instructions for use (ifu) were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.A risk review was completed and confirmed that the event of laser energy emitted straight through the fiber tip and aborted and/or incomplete procedure due to device issue, re-intervention planned is defined in the risk documentation.This investigation is assigned a most probable conclusion code of no problem detected.This conclusion was selected because the reason for device - tripping the breaker and device - unexpected shutdown could not be duplicated/replicated during fse onsite analysis.The conclusion is acceptable because of the analysis of the available information in the complaint did not find/reveal any fault condition(s) within the product.The evidence from the product record review did not identify a potential product quality issue or new patient harm.It can be concluded that the product operates as intended with no issues.

• 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: 50883915
• Report Number: 2124215-2026-50889
• Device Sequence Number: 10708355
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 0010-0210
• 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: 04/23/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 09/24/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown