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

Model Number	M0068F64640
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event was approximated based on the date the manufacturer became aware of the event.Upon receipt of the fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual examination of the fiber found that the connector nut was separated from the fiber.Microscopic examination of the fiber found the fiber tip good and unused, and the connector face had no defects.During, functional testing of the fiber, the console prompted "please connect fiber" and "please dispose applicatory after usage.".The device history record (dhr) was reviewed and indicated that the device met all manufacturing specifications.A review of the device instructions for use (ifu) was completed and states "ensure that the distal end is intact and that the sma connector is clean.Caution: do not use any lighttrail single use laser fiber with damaged distal end or damaged sma connector.Avoid touching the exposed connector end." based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating there was an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the fiber could not be used at the facility due to an unspecified defect.The procedure was completed with another fiber.The fiber was received and analyzed.During initial inspection of the fiber, it was identified that the connector nut was separated from the fiber body; therefore, the reportability criteria are met based on this investigation 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: 22476140
• Report Number: 2124215-2025-46116
• Device Sequence Number: 7943411
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)260112(10)33934489
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 01/12/2026
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0033934489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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