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Model Number OER-6 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the olympus endoscope reprocessor received an e14 "disinfectant is not collected in the tank" error code during operation.After cleaning the mesh, an e12 "insufficient amount of disinfectant in the disinfectant tank" error code was still received.The issue was found during reprocessing.Inspection and testing of the returned device found that a water filter that appeared to be expired was installed; the start date was december 22, 2022.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation.The store representative replaced the switching valve and checked the operation, but e12 continued.The error was resolved eventually.The scopes used in this case were pcf-h290di w/br, gif-n260, gif-pq260, gif-xp260, gif-xp260ns, gif-xp260ns, gif-1200n w/br the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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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, a definitive root cause of the reported replacement of the water filter was not being implemented could not definitively be determined, however, the issue was likely the result of it the user not reading the instruction manual carefully and or made a mistake in the user management of the water filter replacement.The event can be detected/prevented by following the instructions for use which states: instructions, operation manual for oer-6, chapter 7 ¿routine maintenance¿ section 7.3 replacing the water filter (maj-2317)¿ replace the water filter periodically, at least once per two months to prevent contamination of the rinse water.The water filter should also be replaced whenever the error code [e01] indicating water supply insufficiency is displayed.Replace the water filter according to the procedure described below.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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