Model Number UHI-4 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
malfunction
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Event Description
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The customer reported the high flow insufflation unit's ¿air flow increased continuously¿.There was no report of harm or medical intervention with this event.During inspection of the customer returned device, the manifold unit was malfunctioning without gas leakage.This report is being submitted for the event found at evaluation.
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Manufacturer Narrative
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Evaluation of the device revealed that the manifold unit was defective, causing the reported phenomenon.The cause of the defect has not yet been established.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 approved 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, the definitive root cause of the defective manifold unit could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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