Model Number 0010-2400 |
Device Problems
Break (1069); Fracture (1260); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/22/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a prostate procedure, tip rupture occurred after 18,608j of fiber use.The case was completed with a second fiber resolving the event.
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Manufacturer Narrative
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This report is for the same event as manufacturer report number: 2937094-2018-01029.
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Event Description
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It was reported that during a prostate procedure, tip rupture occurred after 18,608j of fiber use.A second fiber was chosen to continue with the procedure; however, the same issue occurred after 34,355j of fiber use.The tip of the fibers were not cleaned during procedure.The case was completed by transurethral resection of the prostate (turp).No patient/user clinical consequences were reported due to this event.This report is for the first fiber.
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Manufacturer Narrative
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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 outer flow tubing.The glass cap exhibits severe devitrification at output window.The metal cap exhibits severe 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.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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Search Alerts/Recalls
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