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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure this console shut down after hearing the sound of burning inside the machine.After inspecting, burn marks were found inside the console.The procedure was completed with another console and another fiber.There were no patient complications reported.

• 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: 17083883
• Report Number: 2124215-2023-28695
• Device Sequence Number: 6070003
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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: XPS61088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown