Product evaluation: failure analysis for fiber 0010-2090-752h-(b)(4): the fiber cap exhibits signs of melting which formed a hole from the surface to the bevel edge; there is some white unknown substance noted inside the distal end of fiber cap; the glass cap exhibits devitrification at the output area, and detritus adhesion around output area; the heat shrink tubing exhibits minor scratch marks; the fiber appears blackened near the heat shrink tubing open end.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: 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.
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It was reported that during a bph surgical procedure, at 173,215 joules and 15 minutes of time expended, it was noted that "laser irradiation stopped after a few minutes".It was further reported that the beam was irradiated forward.The fiber was exchanged and the second fiber was used to complete the procedure.The tip of the fiber was cleaned during the procedure.No harm to the patient reported.
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