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

Model Number	0010-0210S-G0
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the console displayed error codes 211, 213 and 825.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Event or Problem Description
It was reported that during procedure the console displayed error codes 211, 213 and 825.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The console was field service at the user's facility.Upon inspection of the console, the reported error codes were confirmed.It was determined to be most likely due to a defective laser power supply (lps).After performing the replacement of the lps, the issue was resolved, the console was within specification and functioning as intended.Therefore, the reported allegation was confirmed.

• 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: 19888188
• Report Number: 2124215-2024-46451
• Device Sequence Number: 7254745
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 09/10/2024

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: XPS62058
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/10/2024
• Date Device Manufactured: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown