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

Model Number	M0068F64640
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis, and no defects found on the fiber body.The fiber connector had distorted light exiting the connector face.The observed condition of distorted light exiting the connector can be a result of an internal connector fracture.Additionally, a fracture within the connector can occur during procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.The alledge the ifu states that, carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device and return it for replacement.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure which indicates, expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that a lighttrail laser fiber malfunctioned during procedure.The procedure was completed with another of the same device with no patient complications.The fiber was returned and analysis performed.During the analysis, it was found that the connector had an internal connector fracture.Therefore, reportability is met based on this device finding.

• 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: 22543683
• Report Number: 2124215-2025-48047
• Device Sequence Number: 7013574
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)250612(10)32699052
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 06/12/2025
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0032699052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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