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	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the start of a photoselective vaporization of the prostate (pvp) procedure the fiber port overheated.Another fiber was tried with the same results, the procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse calibrated the laser and replaced the top cover.The reported event was confirmed.The replaced top cover was returned for analysis to our post market quality assurance laboratory.Visual analysis identified that the top cover was in good physical condition.The functional testing found that the cladding ring was out of place.With the cladding ring out of place, the laser energy was being reflected from the outer ring and hitting the fiber connector causing the overheating condition.The console was installed on (b)(6) 2022.The system was last serviced on (b)(6) 2023.The console was fully functional with no issues from that time until the reported event date of (b)(6) 2023.Based on the information available, and analysis results, an evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during the start of a photoselective vaporization of the prostate (pvp) procedure the fiber port overheated.Another fiber was tried with the same results, the procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17592458
• Report Number: 2124215-2023-44477
• Device Sequence Number: 8887219
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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-G0
• Device Catalogue Number: 0010-0210S-G0
• Device Lot Number: XPS62009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male