Model Number 0010-2400 |
Device Problem
Break (1069)
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Patient Problem
Burn(s) (1757)
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Event Date 03/29/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a photo selective vaporization of the prostate procedure, the fiber used presented a light leakage under the handle of the laser catheter which brunt the physician thigh, and there were red laser-size spots on the skin.Due to this, the procedure was completed using another fiber.
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Event Description
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It was reported that during a photoselective vaporization of the prostate procedure, the fiber used presented a light leakage under the handle of the laser catheter which brunt the physician thigh, and there were red laser-size spots on the skin.Due to this, the procedure was completed using another fiber.
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Manufacturer Narrative
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Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.Visual inspection of the fiber was not able to identify any defects.The glass cap exhibited moderate devitrification at the output window, please note that devitrification is a normal degradation of the fiber which occurs through use of the fiber.The metal cap exhibited moderate detritus, indicative of tissue contact.The testing conducted did not identify signs of breakage along the length of the fiber.The reported fiber break was not confirmed.The reported burn is a known risk associated with these devices as indicated in the instructions for use.Based on review of all information available and analysis results, a conclusion code of no problem detected was assigned to this investigation.
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Search Alerts/Recalls
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