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

Model Number	0010-0210
Medical Device Problem Codes	Communication or Transmission Problem (2896); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, errors 171 (under power), 235 (no lps current), 202.11 (lps hardware interlock, interlock open) and 102.9 (rcb hardware interlock bit, pd0 overpower) were displayed.The procedure was cancelled.The patient was under anesthesia.There were no patient complications.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse confirmed the reported errors displayed during the surgery.The fse replaced the q-switch driver which resolved the issue.The laser passed full functional and electrical safety testing.It is likely the damaged q-switch contributed to the reported clinical observations as replacing it resolved the issue.The review completed on the device history record (dhr) for this console confirmed that it met specification prior to release, and the most recent console inspection performed on 24sep2025 found it to be fully functional with no issues until the reported clinical observation.Based on the information available, and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure, errors 171 (under power), 235 (no lps current), 202.11 (lps hardware interlock, interlock open) and 102.9 (rcb hardware interlock bit, pd0 over power) were displayed.The procedure was cancelled.The patient was under anesthesia.There were no patient complications.This event is being reported for aborted/cancelled procedure with or unknown sedation.

• 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: 23596431
• Report Number: 2124215-2025-84333
• Device Sequence Number: 10380128
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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