MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL? SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068F64640
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during usage, the fiber stopped delivering energy, and error m01 was prompted.There was no report of patient or procedure involved.Analysis of the returned device identified a fractured connector.
Additional Manufacturer Narrative
Upon receipt in our quality assurance laboratory, the fiber was thoroughly analyzed.A visual inspection revealed no defects.However, under microscopic inspection, it was found that the tip was degraded and the connector had no light exiting, indicating an internal fracture.Fractures within the connector can occur during the procedural handling of the fiber, whether during setup, use, or reprocessing.This fracture can result in an insufficient aiming beam, low laser energy output, or even a complete inability for the fiber to fire.A functional test confirmed that no aiming beam was present, and the fiber may no longer be usable.It is recommended to connect a new fiber.Error code 1101 was displayed.The complaint against the fiber was confirmed.A review of the device's instructions for use (ifu) was completed.It states: carefully inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device.Return it to boston scientific for replacement.The ifu also states: hold the fiber tip to a non-reflective surface, ensuring that a circular green spot appears.If the spot is weak or not visible, do not use it and return the device to boston scientific for replacement.A review of the device history record (dhr) confirmed that the device met all manufacturing specifications; therefore, the failure was unlikely related to manufacturing.The investigation conclusion code assigned is cause traced to component failure, which indicates an expected or random component failure without any design or manufacturing issue.

• Brand Name: LIGHTTRAIL? SINGLE USE
• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23408083
• Report Number: 2124215-2025-76596
• Device Sequence Number: 9131241
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)260116(10)33786030
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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 Expiration Date: 01/16/2026
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0033786030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown