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

Model Number	M0068F64540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to 08/01/2025, based on the manufacturer became aware of the event.
Event or Problem Description
It was reported that this fiber broke during the contact to the scope.The procedure was completed with different device.There were no patient complications.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 08/01/2025, based on the manufacturer became aware of the event.Upon receipt at our quality assurance laboratory, the returned fiber was thoroughly analyzed.There were no defects found on the fiber, no breaks were observed, and the console read that the fiber was used.Microscope inspection found that the tip was degraded due to normal use.During functional testing the console prompted error code 1101, indicative that the fiber may not be used any longer, and to connect a new fiber.A review of the device history record (dhr) confirmed that the fiber met manufacturing specifications prior to release.A review of the device instructions for use (ifu) was performed and stated to 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.Based on all available information and device analysis, the reported fiber break cannot be confirmed as there were no damages identified that could have caused or contributed to the reported event.
Event or Problem Description
It was reported that this fiber broke during the contact to the scope.The procedure was completed with different device.There were no patient complications.

• 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: 23129387
• Report Number: 2124215-2025-66181
• Device Sequence Number: 9352684
• Product Code: GEX
• UDI-Device Identifier: 08714729939788
• UDI-Public: (01)08714729939788(17)260731(10)36925086
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 07/31/2026
• Device Model Number: M0068F64540
• Device Catalogue Number: M0068F64540
• Device Lot Number: 0036925086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AURIGA XL CONSOLE.
• Patient Sex: Unknown