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 bevel edge and the metal cap are not aligned.The glass cap is protruding from metal cap.The glass cap exhibits severe devitrification at output window.The metal cap exhibits severe detritus adhesion on surface.The outer flow tubing open end exhibits minor scratch marks.The connector cone, segments, and tabs appear in good condition and secured.The fiber connector passed the signature verification fixture test.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.An evaluation conclusion code of cause cannot be traced to device was assigned to this investigation.
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