Model Number 0010-2400 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for the same event as manufacturer report: 2124215-2024-17954.
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Event Description
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It was reported that during a photoselective vaporization of the prostate, a total of three (3) fibers were used.The first fiber broke after 108,295 joules and 10:39 minutes of use.The fiber was replaced, and the case continued with a second fiber; however, this fiber also broke after 218,854 joules and 23:25 minutes of use.The procedure was completed with a third fiber utilizing a total of 625,492 joules and 1:03:07 time of use, with no clinical consequences to the patient.This complaint is for the first fiber.
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Manufacturer Narrative
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This report is for the same event as manufacturer report: 2124215-2024-17954.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber identified there were no damages or defects observed.The glass cap exhibited moderate devitrification, which is a normal degradation, this occurs through use of the fiber and should not be considered a failure mode.The metal cap exhibited severe of debris adhesion, indicative of prolonged tissue contact.The fiber was functionally tested with the hene (helium-neon) laser fixture.The testing conducted did not identify signs of breakage along the length of the fiber.Based on analysis results the fiber showed signs of normal usage and there were no fiber damages identified that could have caused or contributed to the reported.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
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Event Description
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It was reported that during a photoselective vaporization of the prostate, a total of three (3) fibers were used.The first fiber broke after 108,295 joules and 10:39 minutes of use.The fiber was replaced, and the case continued with a second fiber; however, this fiber also broke after 218,854 joules and 23:25 minutes of use.The procedure was completed with a third fiber utilizing a total of 625,492 joules and 1:03:07 time of use, with no clinical consequences to the patient.This complaint is for the first fiber.
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Search Alerts/Recalls
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