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Model Number UHI-4 |
Device Problems
Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Auto Stop (2938); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Upon inspection and testing of the returned device, the reported issue (device cannot stop automatically) was confirmed and found to be caused by a cr board (printed circuit board) failure.It was observed the dampers were broken due to which internal sockets of the cr board were deformed, which resulted in disappearing of the front panel display, and failure of the device to insufflate.It was observed the gas volume could not be measured accurately due to a broken manifold unit.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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It was reported the subject device would not stop automatically.The device is an olympus loaner.There was no patient or procedure involvement.The subject device was returned to an olympus service center for evaluation.During inspection and testing, it was observed the front panel display disappeared, the subject device would not insufflate, and the gas volume could not be measured accurately.
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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.Please see the updates in sections h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely the device does not switch to automatic stop, the front panel display disappeared, and the device does not feed air is due to a broken socket of the printed circuit board due to a damaged dumper.It is likely that the device does not measure the amount of air feeding is due to a broken manifold unit.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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