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

Model Number	0010-0210R
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a treatment, the console displayed error 509 and the error was cleared after turning off and re-plugging the device.When the console turned on again, it presented an unknown power related difficulty.Due to this, the procedure could not be completed.There were no patient complications.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 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 there were no issues with the fuse, volt power supply and voltage to master control board (mcb).It was confirmed that error 509 was in the error logs.The power distribution board (pdb), mcb, touch screen board (tsb) cables were checked, no problems found.However, the monitor went black when it was moved and the error pops up.It was determined that there was a short in the monitor wiring harness and determined the top cover needs to be replaced.After the replacement and installation of the top cover, the monitor was tested moving it in all positions, the device passed full functional testing.No further issues were identified during service, and the console was confirmed to be fully functional.It is likely that the error message resulted from the defective top cover, leading to the reported event.The reported complaint was confirmed.
Event or Problem Description
It was reported that during a treatment, the console displayed error 509 and the error was cleared after turning off and re-plugging the device.When the console turned on again, it presented an unknown power related difficulty.Due to this, the procedure could not be completed.There were no patient complications.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): 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: 17878049
• Report Number: 2124215-2023-54619
• Device Sequence Number: 7666519
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/01/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male