MAUDE Adverse Event Report: COHERENT FLEXIVA TRACTIP; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-396
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, the fiber broke two separate times.It was noted that the fiber snapped in two without catching anything from the scope.The procedure was completed with another of the same fiber.There were no patient complications reported.
Event or Problem Description
It was reported that during insertion, the fiber broke two separate times.It was noted that the fiber snapped in two without catching anything from the scope.The procedure was completed with another of the same fiber.There were no patient complications reported.Boston scientific has been unable to obtain additional information regarding the event date, despite good faith efforts.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

• Brand Name: FLEXIVA TRACTIP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): COHERENT; 32 hampshire rd; salem NH 03079
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21351553
• Report Number: 2124215-2025-07080
• Device Sequence Number: 13012532
• Product Code: GEX
• UDI-Device Identifier: 08714729808169
• UDI-Public: (01)08714729808169
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110685
• 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): 03/27/2025

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 Model Number: 840-396
• Device Catalogue Number: 840-396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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