Product evaluation: failure analysis for fiber (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 metal cap; the distal part of the glass cap is detached and not returned; the glass cap exhibits severe devitrification at output window; the metal cap exhibits severe detritus adhesion on surface, and indication of slight melting on output window; 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 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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It was reported that at 4:06 minutes, 35,659 joules while using the surgical fiber during a bph procedure, the output beam was reported to be malfunctioning.The fiber was replaced and the procedure completed using a second surgical fiber.The patient's outcome was reported as stable and event resolved.
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