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

Model Number	0010-0210
Medical Device Problem Codes	Nonstandard Device (1420); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) serviced a console where the laser power supply (lps) indicator was off; replacing the lps did not resolve the issue.Further inspection revealed a blown fuse on the power distribution board (pdb), which was replaced, but this led to an 821 can bus authentication failure, prompting the return of the pdb for analysis.After installing the new pdb, communication issues between system boards persisted until the resonator was replaced, resolving the problem and confirming the reported event.The returned lps passed visual inspection but didn't pass the functional test as it failed to power on.Analysis of the returned pdb showed the 20 amp laser fuse had burnt open due to an electrical fault which damaged the pdb and caused the system failure.
Event or Problem Description
It was reported that the laser unit displayed error e821 and error: 211 (laser power supply brick fault) followed by error 202.2 (e202 lps hardware interlock).The procedure was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was 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): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; st. paul MN 55112
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22043305
• Report Number: 2124215-2025-29468
• Device Sequence Number: 13016146
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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