Model Number 0010-2400 |
Device Problems
Fracture (1260); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a prostate procedure, forward firing occurred.The case was successfully completed with a second fiber without clinical consequences to the patient.
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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 mild 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.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 prostate procedure forward firing occurred after 143,287j with 18:08 minutes of fiber use.The tip of the fiber was not cleaned during procedure.The case was successfully completed with a second fiber without clinical consequences to the patient.
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Search Alerts/Recalls
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