Analysis of the returned device revealed that 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 moderate detritus adhesion on surface and there was indication of slight melting on the output window.The metal cap output window was misaligned with the red stop sign but the metal cap was not loose within the outer flow tubing.The outer flow tubing open end exhibits minor scratch marks, signs of melting and mild contamination with what is most probably biological material.Based on device analysis, the potential for forward firing may exist.The probable cause of the failure is operational context.The 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.The identified issues noted above may activate the fiberlife function which would modulate the power showing a pulsing beam or system would be placed into standby mode.
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