Model Number UHI-4 |
Device Problems
Gas/Air Leak (2946); Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to an olympus service center for evaluation.During inspection and testing, the customer's reported issues were not confirmed or duplicated.The device functioned according to specification.Service found dust inside of the equipment.The investigation is ongoing; therefore, the 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 technician at the user facility reported that during a routine inspection of the device, a leak was observed, and the insufflation was too slow.There was no patient involvement.
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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 reported issue 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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