Product evaluation: failure analysis for fiber 0010-2400-22045291-(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 moderate charred detritus adhesion on surface; 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.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 20,178 joules the aiming beam fired straight.The fiber was exchanged and at 69,894 joules significantly diminished vaporization efficiency was noted.The fiber was exchanged and the third fiber was used to complete the procedure at 63,240 joules.The tips of the fibers were cleaned during the procedure.No harm to the patient reported.This report is for the second fiber.
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