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 severe char on surface; there is misalignment of the metal cap output window with the red stop sign; the metal cap is not loose within the outer flow tubing; the outer flow tubing open end exhibits minor scratch marks and sign 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 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 at 99,745 joules and 13 minutes of use, the fiber tip came loose during the procedure.The fiber tip was cleaned during the procedure.The procedure was completed using second fiber.Patient outcome was "ok", no injury to the patient was reported.
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