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Model Number UHI-4 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2022 |
Event Type
malfunction
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Event Description
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An olympus high flow insufflation unit loaner device was returned.During the device inspection, it was discovered that the internal gasket was damaged.There was no patient involvement during this event.
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Manufacturer Narrative
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.It was discovered that the internal gasket had been damaged.This component will require replacing.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the reported event (broken inner gasket) was unable to be duplicated.The root cause of this event was unable to be identified.During the device evaluation, it was noted that there was a broken inner damper.However, this defect is not considered severe enough to cause a potential adverse event.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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