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Model Number OER-PRO |
Device Problems
Contamination /Decontamination Problem (2895); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported that he found black foreign material in the basin and circulation mesh filter of his olympus endoscope reprocessor.There was no patient involvement during this event.
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Manufacturer Narrative
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Following the initial report, olympus dispatched a field service engineer (fse) to the user¿s facility.Once there, the fse replaced the hose kit.Following the replacement, he ran an electric test and confirmed that the unit was functioning at oem standards.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
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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.Based on the results of the investigation, the reported black foreign material in the mesh filter could not be identified.The investigation confirmed that the foreign material was generated from the device during reprocessing, however, a root cause of the issue could not be determined, though the hose kit was replaced as a correction for the issue.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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