It was reported that on (b)(6) 2019, a brand new cable 001388lx9 ul pro fused headlight cable 9ft, 275cm melted, burned and browned when using the 00mlx mlx 300w xenon lightsource.There was no patient contact, injury, or surgery delay reported.
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The device was returned to the manufacturer for physical evaluation.A visual inspection of the returned 001388lx9 pro fused fiber optic cable found a deep crease in the jacket approximately 3 inches from the connector at the distal end.Functional testing found the cables exhibited a slight brown color at each end.The reported complaint was confirmed.The fiber ends sustained melting-damaged due to exposure from excessive use from the mlx light source.No manufacturing, workmanship, or material deficiency has been identified.Device identifier: (b)(4).
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