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Model Number OER-PRO |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An olympus field service engineer (fse) was dispatched to evaluate and repair the device.The fse found foreign black dot in the mesh filter and replaced all of the black hoses supplied in the hose kit, completed the water line disinfection process, ran and completed a test cycle with no error and no leaks, left the machine in working order and returned the machine back to the customer for normal operation.The investigation is ongoing, and a definitive 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 customer reported to olympus technical assistance center (tac), during reprocessing, the endoscope reprocessor had black dots in the mesh filter.There was no harm or user injury reported due to the event.
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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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus confirmed the device worked without abnormality after replacing the hose, which was used past its durable life.No information was provided on handling of the equipment by the user such as reprocessing method.Based on the results of the investigation, olympus could not specify the root cause of the suggested event.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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