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

Model Number	0010-0210R
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that console suddenly turned off and would not start.Additionally, a burning smell was noted.There was no further information provided on the procedure or patient outcome.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was serviced onsite by a field service engineer (fse).Replacing the vsb resolved the issue.The reported console smoking allegation was confirmed.Based on analysis results and information available, it is likely that the defective vsb contributed to the reported console allegation.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that console suddenly turned off and would not start.Additionally, a burning smell was noted.Boston scientific has been unable to obtain additional information regarding procedure or patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that console suddenly turned off and would not start.Additionally, a burning smell was noted.Boston scientific has been unable to obtain additional information regarding procedure or patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Updated: block d4: the lot number was removed, as the console is serialized.The console was serviced onsite by a field service engineer (fse).Replacing the voltage select board (vsb) resolved the issue.The reported console smoking allegation was confirmed.Based on analysis results and the information available, it is likely that the defective vsb contributed to the reported issue.Subsequently, the vsb was returned.Upon receipt at our quality assurance laboratory, the vsb failed functional testing, which confirmed the complaint.Evidence from the product record review did not identify any potential product quality issue or new patient harm.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): 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: 21315418
• Report Number: 2124215-2025-06189
• Device Sequence Number: 8214011
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: (01)00878953001906(11)130531(10)XPS50845(21)XPS50845
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2025

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: 0010-0210R
• Device Catalogue Number: 0010-0210R
• Device Lot Number: XPS50845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 08/04/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/21/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown