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

Model Number	M0068F64540
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.The returned fiber identified a break in the fiber cap/tip.Visual inspection of the fiber found that the fiber tip was detached from the body.It is likely that the procedural conditions of the device during use contributed to the fiber tip break.Laser fibers are consumable device and are expected to degrade with use.A fiber tip area could be damaged or kinked during the cutting of the fiber and likely fully broke when energy was applied.A device history record (dhr) review was completed and indicates that the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.A review of the device instructions for use (ifu) was completed and states to carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.And also, hold the fiber tip to a non-reflective surface and ensure that a circular green spot appears.If the spot is weak or not visible, do not use and return the device to boston scientific for replacement.Based on the information available, a conclusion code assigned is cause traced to component failure which indicates that an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during procedure, the fiber was gradually deteriorated.It was noted that the operator had to cut the end of the fiber twice.The procedure was completed with another of the same device.There were no patient complications.Analysis of the returned device identified that the fiber tip was detached from the fiber body.
Event or Problem Description
It was reported that during procedure, the fiber was gradually deteriorated.It was noted that the operator had to cut the end of the fiber twice.The procedure was completed with another of the same device.There were no patient complications.Analysis of the returned device identified that the fiber tip was detached from the fiber body.
Additional Manufacturer Narrative
Block e1: initial reporter email added.Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.The returned fiber identified a break in the fiber cap/tip.Visual inspection of the fiber found that the fiber tip was detached from the body.It is likely that the procedural conditions of the device during use contributed to the fiber tip break.Laser fibers are consumable device and are expected to degrade with use.A fiber tip area could be damaged or kinked during the cutting of the fiber and likely fully broke when energy was applied.A device history record (dhr) review was completed and indicates that the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.A review of the device instructions for use (ifu) was completed and states to carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.And also, hold the fiber tip to a non-reflective surface and ensure that a circular green spot appears.If the spot is weak or not visible, do not use and return the device to boston scientific for replacement.Based on the information available, a conclusion code assigned is cause traced to component failure which indicates that an expected or random component failure without any design or manufacturing issue.

• 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 fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23408431
• Report Number: 2124215-2025-76970
• Device Sequence Number: 8890412
• Product Code: GEX
• UDI-Device Identifier: 08714729939788
• UDI-Public: (01)08714729939788(17)251130(10)36227766
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 11/30/2025
• Device Model Number: M0068F64540
• Device Catalogue Number: M0068F64540
• Device Lot Number: 0036227766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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