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Model Number OER-6 |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.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 olympus endoscope reprocessor had the first e99 outbreak and discovered that there was a mistake in the acecide check method.Even if the checker paper shows white (no concentration) 7 seconds after liquid removal, if it turns black over time, it has been incorrectly determined that there is no problem with the concentration.The issue occurred during reprocessing.There were no reports of patient harm or infections.
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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, it is likely that the event occurred due to the facility staff used the aceside checker incorrectly, judging the concentration to be valid even when the reaction zone of the aceside checker turned black over a long period of time.However, the definitive root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: "before checking the concentration of the disinfectant solution with the acceside checker, carefully read the ¿instruction manual¿ of the acceside checker provided with the equipment, get fully accustomed to the content, and use the accesice checker as instructed.Note 3: the reaction progresses over time and coloration proceeds.Please judge within the specified time." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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