Model Number OER-S |
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 06/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to olympus for evaluation.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, during reprocessing, the endoscope reprocessor displayed error code e99, indicating that many days have passed since the replacement of the disinfectant.It was noted that the disinfectant will be replaced.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.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.It has been over 1 year since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.The following information is stated in the instructions for use (ifu): ¿chapter 3 inspection before use.Checking the disinfectant solution concentration level.On reprocessing an endoscope, always use an acecide checker or a portable concentration checker to check that the disinfectant solution is at an effective concentration.Please be sure to replace the disinfectant solution before the disinfectant effect disappears.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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