Product evaluation: failure analysis for fiber (b)(4): the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone of 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 mild detritus adhesion on surface; the outer flow tubing open end exhibits minor scratch marks.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 during bph procedure three fibers failed.The first fiber failed due to fiber timing or dying out at 200,000 joules and 35 mins of use.The fiber tip (cap) was not cleaned during the procedure.The second fiber failed due to fiber going into standby after 10,000 joules of use.The third fiber also exhibited problems but the procedure was completed using third fiber.Patient outcome: "ok" reported.No injury to patient was reported.
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