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 distal part of the glass and metal cap are detached and were not returned.The glass cap exhibits severe devitrification at output window.The outer flow tubing open end exhibits minor scratch marks and there was the presence of severe contamination, most likely due to 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.An evaluation conclusion code of cause cannot be traced to device was assigned to this investigation.
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