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Model Number OER-ELITE |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
Event Type
malfunction
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Event Description
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It was reported the endoscope reprocessor was missing springs on connector a and connector b.Additionally, there was a pressure error on the oer machine.This was found during reprocessing; there was no report of patient harm.
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Manufacturer Narrative
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The device was not returned to olympus, and it is not expected to be returned for evaluation of the reported issue.Upon an on-site assessment, it was determined that the damage to the connector in the basin was due to aged deterioration.A fse, field service engineer, replaced connector b scope connector in the basin.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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 investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over a year since the subject device was manufactured.Based on the results of the investigation, the customer-reported malfunction was most likely due to the internal springs that may have been missed when connectors in the reprocessing basin were broken.As a result of the breakage, it is likely that the user hit the connectors on something hard, or contributed stress to the connectors.The forward loosening direction was accumulated, which most likely made the connectors deteriorated over time.However, the root cause of the events could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: chapter 3.Inspection before use 5.6 inspecting the connectors check the following for each connector.The connector should be fixed firmly.The o-rings should be free of irregularities such as cracks, tears, or dents.If any irregularity is found, do not use the reprocessor and contact olympus.[warning] do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Olympus will continue to monitor the field performance of this de.
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Search Alerts/Recalls
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