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Model Number UHI-4 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has been returned to olympus for evaluation.During evaluation, it was observed, visual examination did not find any abnormalities, operation confirmation could not find any abnormalities and the reported issue was not confirmed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The customer reported to olympus, during preparation for a therapeutic (laparoscopic) procedure, the air supply of the high flow insufflation unit was stopped even though the stop button was not pressed.Subsequently, the air supply was restarted, and the intended procedure was completed successfully.It was noted, a field service engineer visited and inspected the device, but there was no abnormality.There was no harm or user injury reported due to the event.
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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, and since no device malfunction was confirmed during evaluation, the definitive root cause of the air supply malfunction 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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