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

Model Number	0010-0210S-GZ0
Medical Device Problem Code	Physical Resistance/Sticking (4012)
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 the brake pedal remains activated, it appears that the contact is damaged.
Additional Manufacturer Narrative
This report is being submitted to correct the describe event or problem field (b5) in section b, adverse event/product problem, and the report source and report source (other) fields (g2) in section g, all manufacturers.
Event or Problem Description
It was reported that during preparation prior to procedure, the coagulation pedal remained activated, it appears that the contact is damaged.The procedure was completed using the same generator with a different foot switch with no patient complications.
Additional Manufacturer Narrative
Correction: block e2 health professional.Block e3 occupation.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during preparation prior to procedure, the coagulation pedal remained activated, it appears that the contact is damaged.The procedure was completed using the same generator with a different foot switch with no patient complications.

• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22308263
• Report Number: 2124215-2025-41076
• Device Sequence Number: 15434974
• Product Code: GEX
• UDI-Device Identifier: 08714729979173
• UDI-Public: (01)08714729979173(10)XPS61051
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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: 0010-0210S-GZ0
• Device Catalogue Number: 0010-0210S-GZ0
• Device Lot Number: XPS61051
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 09/19/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/30/2025; 10/15/2025
• Date Device Manufactured: 11/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown