Model Number 0010-2400 |
Device Problems
Break (1069); Fracture (1260); Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/05/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a benign prostatic hyperplasia (bph) procedure, after 107,401 joules and 17:42 minutes of use, it was noted that the fiber broke.A second fiber (same model) was utilized to complete the case.It is unknown exactly when during the procedure the fiber break was observed and/or occurred.No injury reported.
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Manufacturer Narrative
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Analysis of the returned device revealed that 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 detritus adhesion on the surface.The outer flow tubing open end exhibits minor scratch marks.Based on device analysis, the potential for forward firing may exist.The probable cause of the failure is operational context.The 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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Event Description
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It was reported that during a benign prostatic hyperplasia (bph) procedure, after 107,401 joules and 17:42 minutes of use, it was noted that the fiber broke.The tip of the fiber was not cleaned during the procedure.A second fiber (same model) was utilized to complete the case.It is unknown exactly when during the procedure the fiber break was observed and/or occurred.No injury reported.
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Search Alerts/Recalls
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