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Model Number UHI-4 |
Device Problems
Inflation Problem (1310); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported to olympus, the high flow insufflation unit was slow to inflate, does not hold pressure or was unstable.There were no reports of patient harm associated with this event.
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Manufacturer Narrative
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The device has not been received to date.Additional information has been requested regarding this event.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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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 and the device evaluation.Please see updates to d9, h3, h4, h6 and h10.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.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, probable causes of the insufflator being slow to inflate and not hold pressure include, a faulty main board or connection failure of the connecting tube connected to the tube pressure sensor.However, the reported event was not duplicated during the device repair.Therefore, a final root cause was unable to be identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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