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 Type
malfunction
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Event Description
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The customer reported that the subject device would not insufflate.There was no report of patient or user injury associated with this event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
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Manufacturer Narrative
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The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (cannot insufflate) was not confirmed or duplicated.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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.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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