Product evaluation: failure analysis for fiber 0010-2400-22102605-(b)(4): the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge; the fiber proximal to fracture can rotate independently of outer flow tubing; the glass cap exhibits severe devitrification at output window; the metal cap exhibits severe charred detritus adhesion on surface; the outer flow tubing open end exhibits minor scratch marks, and mild contamination, likely biologic.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: 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.
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