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

Model Number	840-391
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber had an energy transmission issue during procedure.Another fiber was used in order to complete the procedure.There were no patient complications reported.The fiber was returned, and analysis identified a fiber connector fracture.
Additional Manufacturer Narrative
The fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual examination revealed the fiber tip was degraded down to the fiber jacket.Laser fibers are consumable devices and expected to degrade with use.The light from the connector face was distorted, indicative of fracture within the connector.The fiber connector may have a developed a microfracture that with continued 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 instructions for use (ifu), bending the fiber at sharp angles may result in fiber damage.

• Brand Name: FLEXIVA
• 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: 17094223
• Report Number: 2124215-2023-29634
• Device Sequence Number: 18099263
• Product Code: GEX
• UDI-Device Identifier: 08714729808145
• UDI-Public: 08714729808145
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: 08/09/2024
• Device Model Number: 840-391
• Device Catalogue Number: 840-391
• Device Lot Number: 0000011460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown