Model Number UHI-4 |
Device Problem
Display Difficult to Read (1181)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2022 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the seven-segment display was defective on the high flow insufflation unit.The numbers could not be identified during an unknown diagnostic procedure.The procedure was completed using with the same device.There was no patient involvement associated with this event.
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Manufacturer Narrative
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The device was sent in for evaluation and the customer¿s allegation was confirmed.It was determined, only part of the indicator light on the front panel lights up when the power is turned on.The investigation is ongoing.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 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, there were defects in the 7-segment display, and numbers were unable to be identified.However, the definitive root cause of the display 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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