MAUDE Adverse Event Report: COHERENT FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-396
Medical Device Problem Codes	Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber stopped working.The procedure was completed with another fiber.There were no patient complications.Analysis of the returned fiber identified a fracture within the connector.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned fiber found the fiber body measured 308.1 cm from the distal tip to the proximal end of the sma connector.The exposed glass tip measured 3 mm and appeared in good condition.During functional testing, there was no light present from the sma connector, indicating there was a fracture within the fiber connector, and in addition, there was also burn marks on the face.A review of the device history record confirmed that the fiber met manufacturing specification prior to release.Based on the analysis results of the fiber, the reported event is confirmed.It is likely that the procedural handling of the device during use contributed to the damage to the fiber.The fiber connector may have a developed a microfracture that with use or handling can become larger resulting in an insufficient aiming beam and low laser energy output this could also have lead to the burn marks observed on the connector face.The device instructions for use states: do not bend fiber at sharp angles.If visible light (aiming beam) can be seen leaking from the fiber, fiber failure may result when therapeutic energy is applied as the fiber is deflected beyond the optical limits of total internal reflection.In the event of reduced or no laser energy output during application the fiber connector may be hot to touch.Carefully remove the fiber from the package.Handle the fiber with care as damage may occur if struck or bent sharply.Inspect and treat the output tip with particular care as it represents the most delicate, easily damaged portion of assembly.

• Brand Name: FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER
• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17414210
• Report Number: 2124215-2023-39998
• Device Sequence Number: 20616749
• Product Code: GEX
• UDI-Device Identifier: 08714729808176
• UDI-Public: 08714729808176
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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: 11/10/2024
• Device Model Number: 840-396
• Device Catalogue Number: 840-396
• Device Lot Number: 0000011723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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