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

Model Number	0010-0210
Medical Device Problem Codes	Smoking (1585); Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the preventative maintenance, the fuse blew.Additional information received informed that the machine screen went white with a goodby message and there was a burning smell.There was no patient involvement.
Event or Problem Description
It was reported that, during the preventative maintenance, the fuse blew.Additional information received informed that the machine screen went white with a goodby message and there was a burning smell.There was no patient involvement.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the facility of the customer by a field service engineer (fse).The fse confirmed there was a burning smell coming from the machine.He replaced the power diode, the master control board (mcb), the voltage select board (vsb) and the filters.It was identified that the vsb had a blown capacitor causing the strong burning smell.A calibration was performed.The laser passed full functional and electrical safety testing.The vsb was returned to quality assurance laboratory, where it was thoroughly analyzed.Analysis identified that sections of the vsb had burned components.The laser power supply (lps) was returned to quality assurance laboratory, where it was thoroughly analyzed.The lps did not pass the functional testing as there was no power.It is most likely that there was an electrical fault with the vsb and the lps which contributed to the reported clinical observations.Based on the information available and service performed, the reported events are confirmed.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22592486
• Report Number: 2124215-2025-48891
• Device Sequence Number: 9052474
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508(11)160801
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/04/2025

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: Other
• Device Model Number: 0010-0210
• Device Catalogue Number: 0010-0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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