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

Model Number	M0068F64500
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.A visual inspection of the returned device found that the fiber body was broken into two pieces.Microscopic inspection found that the tip is in good condition, and the connector has no defects.A functional test was performed and confirmed that the fiber may not be used anymore.A labeling review was performed on the device instructions for use (ifu).The ifu cited 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 the manufacturer for a replacement.A device history record review (dhr) was performed and confirmed that the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.There was no reported complaint, thus a complaint confirmation could not be done.It is likely that procedural conditions of the device during set-up or use contributed to the fiber body break.Based on the information available, the most probable cause was 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 one lighttrail device was returned.There was no report of patient or procedure involved.Analysis of the returned device found that the fiber body was broken.

• 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: 24402557
• Report Number: 2124215-2026-09575
• Device Sequence Number: 10113830
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: (01)08714729939764(17)260219(10)36732461
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 02/19/2026
• Device Model Number: M0068F64500
• Device Catalogue Number: M0068F64500
• Device Lot Number: 0036732461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown