Model Number UHI-4 |
Device Problems
Contamination (1120); 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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Manufacturer Narrative
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The suspect device was sent to an olympus service center for evaluation.Inspection and testing found oil leakage in the tube due to the defective inner parts of the device.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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Event Description
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The customer reported that, during preparation for an unspecified diagnostic procedure, the insufflation unit was found to have a damaged regulator and tube.The procedure was completed with a similar device.The subject device was sent to an olympus service center for evaluation.During inspection and testing, oil was found in the tube.This report is being submitted for the reported malfunction and the malfunction found during evaluation (foreign material).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 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, the cause of the phenomenon is likely due to a broken tube that lead to oil leaking.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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