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

Model Number	0010-0210
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console has a broken water reservoir.The plastic connector is also sheared off.Due to this, the procedure had to be cancelled.This event is being reported for aborted/cancelled procedure with a patient 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24834982
• Report Number: 2124215-2026-19433
• Device Sequence Number: 10306357
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: (01)00878953005508(10)XPS50989
• 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): 05/07/2026

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
• Device Lot Number: XPS50989
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 11/05/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown