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

Model Number	69269
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	04/01/2024
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 fiber body found no defects.During the product analysis, the exposed tip was 5 mm and in good condition.There was a distorted light exiting the connector face, indicating a connector fracture and burn marks was also observed.Additionally, the aim beam was weak.The reported event was confirmed.The device instructions for use (ifu) indicates that the ifu contains appropriate instructions and warnings for use.Based on the investigation 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.This internal connector fracture likely caused the connector to overheat leading to burn mark on the connector face.The ifu states that in the event of reduced or no laser energy output during application the fiber connector may be hot to touch.Do not exceed the recommended maximum power levels associated with the selected fiber size.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.Carefully inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to boston scientific for replacement.Hold the fiber tip to a non-reflective surface and ensure that a circular red spot appears.Finally, 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.
Event or Problem Description
It was reported that the laser fiber was not transmitting properly.No patient complications reported.Analysis of the returned device identified a connector fracture.

• Brand Name: FLEXIVA ID
• 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: 19629169
• Report Number: 2124215-2024-39423
• Device Sequence Number: 7065407
• Product Code: GEX
• UDI-Device Identifier: 08714729963790
• UDI-Public: 08714729963790
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 07/01/2024
• Device Model Number: 69269
• Device Catalogue Number: 69269
• Device Lot Number: 0000011312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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