MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS GreenLight XPS; Powered Laser Surgical Instrument

Model Number	0010-0210R
Medical Device Problem Codes	Insufficient Cooling (1130); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error code 652 (the chiller did not sense flow after the timeout period) occurred during a photo-selective vaporization of the prostate procedure.There were no patient complications; however, the procedure could not be completed.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 confirmed error 652, and replaced the chiller.A calibration was performed.The laser console passed full functional and electrical safety testing.Based on the analysis results, the reported error message was confirmed as replacing the chiller resolved the issue.The chiller was likely damaged and is most likely the reason that caused the reported error message.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that error code 652 (the chiller did not sense flow after the timeout period) occurred during a photo-selective vaporization of the prostate procedure.There were no patient complications; however, the procedure could not be completed.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 error code 652 (the chiller did not sense flow after the timeout period) occurred during a photo-selective vaporization of the prostate procedure.There were no patient complications; however, the procedure could not be completed.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
The console was serviced onsite by a field service engineer (fse).The fse confirmed error code 652 and replaced the chiller.A calibration was performed, and the console passed full functional and electrical safety testing.Based on the analysis results, the reported error message was confirmed, and replacing the chiller resolved the issue.The chiller was likely damaged and is most likely the reason that caused the reported error message.Subsequently, the chiller was returned for additional testing and repairs.It was determined that the water pump had failed.It can therefore be concluded that an electrical fault with this old chiller was the most probable cause of the reported error message.A review of device history record (dhr)/service history record (shr) was performed and indicated that the device was installed on 13 march 2013.This device is covered under a semi-annual pm service contract.It was last service on 1 july 2024.The device was fully functional from that date until the reported complaint date of 12 november 2024.A risk review was completed and confirmed that the event of device displays 600 (chiller) error was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device instructions for use (ifu) was performed and found there was no evidence that the console was used in a manner inconsistent with the labeling.Based on the available information and analysis results, the conclusion code cause traced to component failure was assigned to this investigation.

• Brand Name: GreenLight XPS
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; innovation ctr, silicon valley; 3070 orchard drive; san jose CA 95134 -201
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive; san jose CA 95134 -201
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20790742
• Report Number: 2124215-2024-73705
• Device Sequence Number: 7894788
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2026

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: 0010-0210R
• Device Catalogue Number: 0010-0210R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 04/02/2025; 08/11/2026
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/30/2025; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown