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

Model Number	0010-0210
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to procedure the console display screen went white after plugging in the fiber.It was turned off, removed fiber, turned back on, plugged in the fiber, still got the white screen.Biomed checked on the laser after, turned on the laser, with the fiber removed and the screen was white still.The patient was under general anesthesia, staff woke up the patient in stable condition, no injury for patient but the procedure had to be canceled due to this event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that prior to procedure the console display screen went white after plugging in the fiber.It was turned off, removed fiber, turned back on, plugged in the fiber, still got the white screen.Biomed checked on the laser after, turned on the laser, with the fiber removed and the screen was white still.The patient was under general anesthesia, staff woke up the patient in stable condition, no injury for patient but the procedure had to be canceled due to this event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The console was 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, the reported allegation of display screen - no display or display failure was confirmed.The top cover was replaced, and the issue was solved.Most likely the defective top cover could have affected the device performance.No further issues were identified during service, and the console was confirmed to be fully functional after replacing.

• 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): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive; san jose CA 95134 2011
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20906086
• Report Number: 2124215-2024-76830
• Device Sequence Number: 9155621
• Product Code: GEX
• UDI-Device Identifier: 00878953005508
• UDI-Public: 00878953005508
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 0010-0210
• Device Catalogue Number: 0010-0210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 08/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown