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

Model Number	0010-0210S-GZ0
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a prostate ablation procedure, the console launches an emergency shutdown message, and 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 the air filter was completely clogged by dust which causes the chiller to overheat.The fse proceeded to perform a visual inspect to the defective chiller filter and it was replaced, resolving the complaint.No further issues were identified during service, and the console was confirmed to be fully functional after the replacement.It is likely that the error message resulted from the defective chiller filter, leading to the reported event.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a prostate ablation procedure, the console launches an emergency shutdown message, and 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17687544
• Report Number: 2124215-2023-47306
• Device Sequence Number: 20341660
• Product Code: GEX
• UDI-Device Identifier: 08714729979173
• UDI-Public: 08714729979173
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 0010-0210S-GZ0
• Device Catalogue Number: 0010-0210S-GZ0
• Device Lot Number: XPS61100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown