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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Insufficient Cooling (1130); Electrical /Electronic Property Problem (1198); Nonstandard Device (1420); Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior the pvp (photoselective vaporization of the prostate) procedure for benign prostatic hyperplasia, the console is stuck displaying, please wait.It was noted the console displayed error 302.13 (mcb.Hardware interlock bit) and error 632 (warmup timeout).The procedure was discontinued.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
Correction to a1: patient identifier.Correction to a3: gender.The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the reported error 1413 displayed by the console was caused by a defective chiller and a cracked copper tube.The fse proceeded to perform the visual inspection, concluding in the replacement of these components and recharging the coolant in system, to ensure the system temperature works in normal operating specifications.The laser console was calibrated and finally, the device passed full functional and electrical safety testing.No further issues were identified during service, and the console was confirmed to be fully functional after repairs.It is likely that the error message resulted from the defective components, leading to the reported event.The reported complaint was confirmed.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that prior the pvp (photoselective vaporization of the prostate) procedure for benign prostatic hyperplasia, the console is stuck displaying, please wait.It was noted the console displayed error 302.13 (mcb.Hardware interlock bit) and error 632 (warmup timeout).The procedure was discontinued.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: 22160067
• Report Number: 2124215-2025-36450
• Device Sequence Number: 7422019
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: (01)08714729979135(10)XPS62052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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-G0
• Device Catalogue Number: 0010-0210S-G0
• Device Lot Number: XPS62052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown