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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Failure to Power Up (1476); Smoking (1585); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console prompted error codes 211, 213, and 302.13.The console is no longer powering on and is smoking.The procedure was completed with another console and no patient complications.
Additional Manufacturer Narrative
The service repair was performed on site by the field service engineer (fse).During service repair, the fse was able to power up the console, and confirmed the 211 (laser power supply brick fault), 213 (laser power supply off setpoint) and 302 (master control board hardware interlock bit) error codes.The fse tried to calibrate the console.The console did not pass the testing.The laser power supply (lps) and resonator were replaced.The console was calibrated, it passed the electrical safety testing and works properly according to all boston scientific (bsc) specifications.The replaced lps and resonator were received at bsc for further investigation.The lps is enclosed in a metal enclosure with no opening to inspect the inside of the unit.The external visual inspection found it in over all good physical condition.No physical damage was observed that could have contributed to the reported complaint.The lps passed incoming functional testing.The exterior of the resonator was found in overall good physical condition.Frozen indicator was purple.This indicates that the resonator was exposed to freezing temperatures, possibly during transport.If water was inside the unit at that time, the freezing could induce internal damage.The resonator was repaired by replacing the fiber coupler and freeze indicator.The repair was completed, and routine preventative maintenance service was performed.The device history record (dhr) review and service history record review was completed and confirmed that the console was last serviced on 12 february 2023 and the console was fully functional with no issues.A review of the device instructions for use (ifu) and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on investigation results, the reported event of smoking, failure to power-up, device displays 200 (lps) error message and device displays 300 (master control board) error message was confirmed.The smoking issue was most likely caused by component failure in the resonator.The electrical issues in the resonator can trigger additional error codes such as the reported 200 and 300 series error codes.Based on the observed electrical issues and physical damage to the resonator, an evaluation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console prompted error codes 211, 213, and 302.13.The console is no longer powering on and is smoking.The procedure was completed with another console and no patient complications.

• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17813661
• Report Number: 2124215-2023-52343
• Device Sequence Number: 6691618
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: XPS61046
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male