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

Model Number	0010-0210
Medical Device Problem Codes	Failure to Power Up (1476); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.
Event or Problem Description
It was reported that biomed, stated the unit would not power on.The console was brought to biomed after producing a burning smell; however, when attempting to power it back on, it failed to start and error codes could not be confirmed.No patient involvement was reported.
Event or Problem Description
It was reported that biomed, stated the unit would not power on.The console was brought to biomed after producing a burning smell; however, when attempting to power it back on, it failed to start and error codes could not be confirmed.No patient involvement was reported.
Additional Manufacturer Narrative
Upon receipt of the device, the unit was evaluated and troubleshooting was performed.Service records (wo (b)(4)) indicate that the voltage selector board (vsb) was identified as the malfunctioning component.The vsb was replaced, detectors were set, and the laser was calibrated.Functional testing at multiple power settings confirmed that the system operated normally and met engineering specifications after the repair.The reported burning smell and failure to power on are consistent with an electrical component malfunction.In this case, evidence indicates that the voltage selector board experienced an internal failure leading to overheating and loss of power functionality.A review of the product hazard analysis/fmea (document (b)(4)) confirmed that failure to power and smoking are recognized hazards already addressed within the product risk controls.Based on the available evidence and the results of the repair, the most probable cause of the event is component failure of the voltage selector board (vsb), with no indication of a broader product quality 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 2011
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; innovation ctr, silicon valley; 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: 23547276
• Report Number: 2124215-2025-80833
• Device Sequence Number: 9327004
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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
• Device Lot Number: XPS50132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown