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

Model Number	840-396
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Adverse Event Without Identified Device or Use Problem (2993); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The fiber device received in one piece and no defects to the fiber body; however, the tip was degraded down to the fiber jacket.There was no light exiting the connector face, indicating that the connector was fracture.A media was provided by the physician and shows that the card box of the device was damaged.Additionally, it shows that the fiber has no packaging inside the box.The reported event was confirmed.The device instructions for use (ifu) indicates that the ifu contains appropriate instructions and warnings for use.A fracture within the sma connector can occur during procedural handling of the fiber during setup or use.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, up to a complete inability for the fiber to fire.The ifu instructs the user to carefully inspect that the fiber tip and aiming beam are in clear view and at a safe distance from the tip of the endoscopic delivery system when laser energy is being applied.In the event of reduced or no laser energy output during application the fiber connector may be hot to touch.Ensure that the sterile packaging is not open, torn or punctured and the product is not damaged.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.Additionally, hold the fiber tip to a non-reflective surface, and ensure that a circular red spot appears.If the spot is weak or not visible, do not use and return the device to boston scientific for replacement.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure which indicates, expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the fiber packaging appeared to be used.The box appeared to be old, crushed, and the seal appeared to have been opened.No further information was reported.Analysis of the returned device identified a fiber break.

• Brand Name: FLEXIVA TRACTIP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): COHERENT; 32 hampshire rd; salem NH 03079
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19122566
• Report Number: 2124215-2024-22412
• Device Sequence Number: 15360734
• Product Code: GEX
• UDI-Device Identifier: 08714729808169
• UDI-Public: 08714729808169
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: 09/07/2024
• Device Model Number: 840-396
• Device Catalogue Number: 840-396
• Device Lot Number: 0000011539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown