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Model Number CYF-V2 |
Device Problems
No Display/Image (1183); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the viseravideoscope was blown and did not have the pressure cap on.The issue was found during reprocessing.There were no reports of patient harm.
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Manufacturer Narrative
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Updated: h6, h10.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause of the reported pressure cap not attached during reprocessing and the scope was blown issue could not be determined, however, the issue was likely the result of user mishandling/user misuse.The event may be detected/prevented by following the instructions for use which states: visera cysto-nephro videoscope; olympus ltd type v2; olympus ltd type va2.Olympus ltd type v2r; chapter 5 reprocessing: general policy; chapter 6 compatible reprocessing methods and chemical agents; chapter 7 cleaning, disinfection, and sterilization procedures; olympus will continue to monitor field performance for this device.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the investigation results.The device failed the dunk test and was taped and still leaking, the scope blow out was confirmed, the device was chipped and lifting, there was a heavy dent, a failed ring gauge, and a cracked master case and master plug.
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Search Alerts/Recalls
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