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

Model Number	0010-0210S-GZ0
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console displayed error code 660 during procedure.The console was turned off for safety and then error coded 611 and 831 were displayed, therefore, the day was suspended.There was no procedure and patient outcome reported.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
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 performed a physical inspection of the console, as well was power-on tests, however there were no issues found within the console.During the inspection, the event reported of error codes 660, 611 and 831 could not be replicated by the fse.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the console displayed error code 660 during procedure.The console was turned off for safety and then error coded 611 and 831 were displayed, therefore, the day was suspended.There was no procedure and patient outcome reported.A full service was performed on the console; however no issues were observed during the evaluation.Also, was informed that the city where the equipment is located has been experiencing issues with the electrical grid, and that electrical irregularities may be contributing to the reported errors.

• 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: 22032100
• Report Number: 2124215-2025-29214
• Device Sequence Number: 13132402
• Product Code: GEX
• UDI-Device Identifier: 08714729979173
• UDI-Public: (01)08714729979173(10)XPS62012
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: XPS62012
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown