Model Number OER-ELITE |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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In troubleshooting, the customer replaced the filter with an old filter and the issue was resolved.Technical assistance center (tac) advised the customer to not use alignment rings inside the canister for the filter and that resolved the issue.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported, the endoscope reprocessor was leaking.It is unknown when the issue was observed.There were no reports of patient injury or harm.
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Event Description
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The reported event occurred during preventative maintenance.There were no reports of patient involvement.
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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 investigation results, the reporter indicated that the issue was resolved but did not specify how the issue was resolved.As the device was not returned to olympus for evaluation, a definitive root cause could not be determined.The event can be detected/prevented by following the instructions for use: 8.4 replacing the water filter (maj-824 or maj-2318).Open the bottom (the side without the o-ring) of the package containing the new water filter.Place the new water filter directly from the bag into the water filter housing so that o-ring will be positioned upward.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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