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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Insufficient Cooling (1130); Electrical /Electronic Property Problem (1198); Nonstandard Device (1420); Use of Device Problem (1670); Device Displays Incorrect Message (2591); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a procedure, the console did not start up and it displayed error codes 641, 302.13, and 202.11.The console was rebooted, but the error codes did not clear.There were no patient complications.However, the procedure was cancelled.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 and replaced the defective chiller, since the console prompted error codes related.Thus, the event reported was confirmed.The fse also checked the output and cooling water flow rate and adjusted the console output.After that, the console was working within specifications.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that prior to a photo selective vaporization procedure for bladder stone, the console was started, but then the device was turned off in order to switch the power supply.After that the console did not start up and it displayed error codes 641, 302.13, and 202.11.The console was rebooted, but the error codes did not clear.There were no patient complications.However, the procedure was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Event or Problem Description
It was reported that prior to a photo selective vaporization procedure for bladder stone, the console was started, but then the device was turned off in order to switch the power supply.After that the console did not start up and it displayed error codes 641, 302.13, and 202.11.The console was rebooted, but the error codes did not clear.There were no patient complications.However, the procedure was cancelled.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 an inspection of the console and confirmed the error codes 641 (chiller serial not set), 302.13 (master control board hardware interlock bit) and error 202.11 (laser power supply hardware interlock), thus, confirming the reported event.The fse inspected the console and found a water leak, which was sealed.The chiller was replaced and the software reloaded, and the issue regarding the error codes was resolved.The console was working within specifications.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that prior to a photo selective vaporization procedure for bladder stone, the console was started, but then the device was turned off in order to switch the power supply.After that the console did not start up and it displayed error codes 641, 302.13, and 202.11.The console was rebooted, but the error codes did not clear.There were no patient complications.However, the procedure was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
The 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 an inspection of the console and confirmed the error codes 641 (chiller serial not set), 302.13 (master control board hardware interlock bit) and error 202.11 (laser power supply hardware interlock).The error codes were displayed due to a an electrical and software issue of the console; therefore, the reported event was confirmed.The fse inspected the console and found a water leak in the chiller, which was sealed.Normally, during the installation of the device, the chiller would be programmed, and the system recognize the chiller was in place.The error codes were associated with a software issue, since the chiller lose its profile information, and the system could not read the chiller, and that lead to the errors.The fse reinstalled the profile information of the chiller and the issue was solved.However, the day after that, the profile information of the chiller was missing again.The fse checked the chiller and found an electrical issue causing the information lost.The chiller was replaced and the issue regarding the error codes was resolved.The console was working within specifications and passed the functional and electrical safety tests.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
The 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 an inspection of the console and confirmed the error codes 641 (chiller serial not set), 302.13 (master control board hardware interlock bit) and error 202.11 (laser power supply hardware interlock).The error codes were displayed due to a an electrical and software issue of the console; therefore, the reported event was confirmed.The fse inspected the console and found a water leak in the chiller, which was sealed.Normally, during the installation of the device, the chiller would be programmed, and the system recognize the chiller was in place.The error codes were associated with a software issue, since the chiller lose its profile information, and the system could not read the chiller, and that lead to the errors.The fse reinstalled the profile information of the chiller and the issue was solved.However, the day after that, the profile information of the chiller was missing again.The fse checked the chiller and found an electrical issue causing the information lost.The chiller was replaced and the issue regarding the error codes was resolved.The console was working within specifications and passed the functional and electrical safety tests.The chiller was returned and analyzed.The visual and functional testing were performed, and the chiller passed both tests successfully.It was suggested that the most likely reason for the previous failure, was due to software glitch that trigger the missing information of the serial number fault.Based on analysis and the information available; a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that prior to a photo selective vaporization procedure for bladder stone, the console was started, but then the device was turned off in order to switch the power supply.After that the console did not start up and it displayed error codes 641, 302.13, and 202.11.The console was rebooted, but the error codes did not clear.There were no patient complications.However, the procedure was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• Brand Name: GREENLIGHT XPS LASER SYSTEM
• 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: 19711205
• Report Number: 2124215-2024-41471
• Device Sequence Number: 20984800
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/26/2026

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: XPS62021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 10/14/2024; 01/23/2025; 02/05/2026
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/14/2024; 11/04/2024; 02/11/2025; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown