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

Model Number	0010-0210S-GZ0
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console displayed errors 211 (laser power supply brick fault) and 213 (lps off setpoint).The console powered off and did not turn power on again.Due to this, the procedure could not be completed when the patient was under general sedation.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• 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): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24614113
• Report Number: 2124215-2026-14548
• Device Sequence Number: 10181456
• Product Code: GEX
• UDI-Device Identifier: 08714729979173
• UDI-Public: (01)08714729979173(10)XPS62056
• 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): 06/09/2026

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: 0010-0210S-GZ0
• Device Catalogue Number: 0010-0210S-GZ0
• Device Lot Number: XPS62056
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 07/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 57 KG