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

Model Number	0010-0210S-G0
Medical Device Problem Codes	Poor Quality Image (1408); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, in preparation for the photoselective vaporization of the prostate procedure, the patient had been given general anesthesia.While preparing for the procedure, error 521 (language initialization failed) occurred when the console was started up.Additionally, the letters on the monitor were displayed sideways.The console and breaker were turned off, the customer waited 30 seconds, and then the console was restarted.Error 521 no longer appeared.However, the letters on the console screen were still displayed sideways.The console was turned of and on multiple times but the issue did not resolve.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
Upon receipt of the lcd screen at our quality assurance laboratory, the device was thoroughly analyzed.Visual inspection showed normal wear and tear on the body.Functional testing found the lcd turned on and started up.However, the screen was distorted, and the touch screen is off because of it.
Event or Problem Description
It was reported that, in preparation for the photoselective vaporization of the prostate procedure, the patient had been given general anesthesia.While preparing for the procedure, error 521 (language initialization failed) occurred when the console was started up.Additionally, the letters on the monitor were displayed sideways.The console and breaker were turned off, the customer waited 30 seconds, and then the console was restarted.Error 521 no longer appeared.However, the letters on the console screen were still displayed sideways.The console was turned of and on multiple times but the issue did not resolve.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

• 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: 18817486
• Report Number: 2124215-2024-12581
• Device Sequence Number: 17271154
• Product Code: GEX
• UDI-Device Identifier: 08714729979135
• UDI-Public: 08714729979135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/24/2024

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: XPS61188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male