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

Model Number	0010-0210
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with the system due to during surgery the green light was flashing yellow, and it has caused the cancelation of a number of surgeries.No further information was provided.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that there was an issue with the system due to during surgery the green light was flashing yellow, and it has caused the cancelation of a number of surgeries.No further information was provided.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation 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 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: 21968278
• Report Number: 2124215-2025-28598
• Device Sequence Number: 15557212
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508(11)160801
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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
• Device Lot Number: OEMTRACE
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 08/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown