It was reported that during a prostate procedure, the tip of the fiber broke during use.The physician cleaned the tip twice during the procedure.The fiber was reported to have been used for 22 minutes at 230,000j.The case was completed with a second fiber.The patient's outcome was reported as stable.
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Analysis of the returned device revealed 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 is detached and returned.The metal cap is detached and not returned.The glass cap exhibits severe devitrification at output window.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.The probable 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.An evaluation conclusion code of cause cannot be traced to device was assigned to this investigation.
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