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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, the fiber broke without being bent or damaged.There were no fragments that fell inside the patient.The procedure was completed using another of the same device.There were no patient complications.
Event or Problem Description
It was reported that during insertion, the fiber broke without being bent or damaged.There were no fragments that fell inside the patient.The procedure was completed using another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.A visual inspection found that the fiber was broken.The fiber was received.The tip was in good condition.The connector had no defects.A functional test was performed and noted that the fiber may not be used anymore.Code 1101.The product record review (prr) results did not determine any anomalies in the manufacturing documentation, and the failure mode was not unanticipated or new to the manufacturer.A labelling 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 to be damaged, do not use the device.Return it to the manufacturer for replacement.A risk review was completed and confirmed that the event of a fiber breaking was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A device history record review was performed, and it indicates that the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.Based on the information available, the investigation conclusion code selected for this complaint is cause traced to component failure.

• 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: 23981090
• Report Number: 2124215-2026-00746
• Device Sequence Number: 10608974
• Product Code: GEX
• UDI-Device Identifier: 08714729939788
• UDI-Public: (01)08714729939788(17)260916(10)36311674
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 03/23/2026

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: 09/16/2026
• Device Model Number: M0068F64540
• Device Catalogue Number: M0068F64540
• Device Lot Number: 0036311674
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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