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Model Number UHI-4 |
Device Problem
Intermittent Loss of Power (4016)
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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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Upon further evaluation, service could not duplicate or confirm the customer¿s reported intermittent power issue; however, it was recommended that the main board be replaced as this may cause the reported intermittent power issue.Service also found the set pressure indicator had a dead light emitting diode (led) element.In addition, service found the front panel was cracked near the gas inlet, the front chassis was damaged near the power button, and the bottom chassis was deformed.The investigation is ongoing; therefore, a 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 biomedical engineer at the user facility reported that the subject device had intermittent power and that during the procedure, it was shutting itself off many times.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.During inspection and testing, service found error code e03 (excessive pressure when inflated/pressure sensor abnormality) was noted in the device error log 10 times.This report is being submitted for the intermittent power and error code e03.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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This report is being supplemented to provide additional information based on the approved final investigation and to correct the manufacturing date in h4.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 faulty main board could not be determined.Error code e03 occurs when an abnormality is detected in the pressure sensor due to excessive pressure at the time of inflation.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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