It was reported that during a benign prostatic hyperplasia (bph) procedure, after 255,599 joules and 33 minutes of use, it was noted that the fiber tip appeared melted and the aiming beam was observed to be firing straight out of the fiber.A second fiber was utilized to complete the procedure.No injury reported.
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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 outer flow tubing; the glass cap exhibits severe devitrification at output window; the metal cap exhibits mild detritus adhesion on surface; the fiber tip exhibits no signs of melting; 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 product complaint "fiber cap melted" could not be confirmed.Glass cap fracture observed.The probable root cause of the failure is: operational context.Additional information: the probable root 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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