Model Number OER-PRO |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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A user facility reported that the detergent lamp was illuminated.There was no patient involvement or injuries reported.No additional information has been obtained.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, further troubleshooting with the customer and a review of the device history record (dhr) were conducted.An olympus technical service representative helped troubleshoot the issue with the customer.After the customer ran another cycle on the device, the detergent light reset and the device functioned normally.No other issues have occurred.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause of the detergent replacement indicator was traced to not running a reprocessing cycle after the detergent bottle was replaced.Running a cycle reset the indicator.No device problem was identified.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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