Product evaluation: failure analysis for fiber (b)(4): the fiber cap exhibits signs of melting which formed a hole from the surface to the bevel edge; there is some white unknown substance noted inside the distal end of fiber cap; the fiber cap exhibits a crack on the bevel edge.The glass cap exhibits severe devitrification at the output area, and detritus adhesion around output area; the fiber appears blackened near the heat shrink tubing open end; the heat shrink tubing exhibits minor scratch marks.Based on device analysis, the potential for forward firing may exist.Probable root cause: based on the device analysis, the probable root cause of the failure is: heat accumulation.Cap wear was accelerated due to anatomical/procedural factors (tissue contact and technique) encountered during the procedure which would limit the performance of the fiber.
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