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 glass cap exhibits devitrification at the output area, and detritus adhesion around output area; the heat shrink tubing exhibits signs of melting, and partially erased red octagonal sign and blue arrow indicator.Based on the 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: operational context.The probable root cause was determined based on 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.Fiber cap condition would result in reduced vaporization efficiency.Review of lot 715h dhr did not indicate any failures upon final inspection.
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