Model Number 0010-2400 |
Device Problems
Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2017 |
Event Type
malfunction
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Event Description
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It was reported that during a bph procedure, tip rupture (interpreted as tip broken) occurred during use of the fiber.A second fiber was utilized to complete the case.The patients condition following the procedure was reported as stable.
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Event Description
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Additional information received noted: joules used: 86000, time expended: 11 mins.The fiber tip (cap) was cleaned during the procedure.The tip of the laser is broken was reported.
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Manufacturer Narrative
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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 metal cap; the distal part of the glass cap is detached and not returned; the glass cap exhibits severe devitrification at output window; the metal cap exhibits severe charred detritus adhesion on surface; the outer flow tubing open end exhibits minor scratch marks.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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Search Alerts/Recalls
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