Product evaluation: failure analysis for fiber 0010-2400-21885133-(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 glass cap and metal cap are detached and not returned; the glass cap exhibits severe devitrification at output window; the outer flow tubing open end exhibits minor scratch marks and signs of melting.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.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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It was reported that during a benign prostatic hyperplasia surgical procedure at 199,935 and 24:26 minutes the beam fired straight, the fiber was defective, and no longer worked.The fiber was exchanged and the second fiber was used to complete the procedure.No harm to the patient reported.
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