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

Model Number	0010-0210R
Medical Device Problem Codes	Failure to Power Up (1476); Smoking (1585); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case, the device powered down suddenly and will not power on anymore.It was also observed that a large capacitor began to smoke.No information regarding the patient was provided.

• 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: 24665073
• Report Number: 2124215-2026-15815
• Device Sequence Number: 5055407
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: (01)00878953001906(11)150805(10)XPS60213
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: XPS60213
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 08/05/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown