MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT XPS; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-0210
Medical Device Problem Codes	Smoking (1585); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the device had an unexpected shutdown and a short-circuit smell was detected.It was also noted that an attempt to restart the device was unsuccessful and testing it in a different outlet also failed to turn it on.The procedure was completed with different device.There were no patient complications.
Event or Problem Description
It was reported that during the procedure, the device had an unexpected shutdown and a short-circuit smell was detected.It was also noted that an attempt to restart the device was unsuccessful and testing it in a different outlet also failed to turn it on.The procedure was completed with different device.There were no patient complications.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse confirmed the smoking and unexpected shutdown.A test was performed on the equipment by forced shutdown at the client site, the equipment failed to power on, and the voltage selector card did not produce the expected clicking sound when energized.The chiller was removed to inspect the card and toroidal transformer.The card was found completely burned due to a capacitor explosion.The card was replaced, and input/output voltages were verified as correct.When the ignition switch was activated, the card responded normally.However, upon attempting to start the equipment using the keys, a brief sound was heard, and the new card failed in the same way.This indicates a short circuit in the toroidal transformer.As this component cannot be replaced locally, the equipment must be returned to the factory for repair.Therefore, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: GREENLIGHT XPS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 21809109
• Report Number: 2124215-2025-21700
• Device Sequence Number: 12961562
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508(11)160928
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 09/28/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male