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Model Number OER-PRO |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2022 |
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 technical assistance center (tac), the yellow scope connector of the endoscope reprocessor was cracked.There was no patient involvement in this 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.An olympus field service engineer (fse) was dispatched to the facility.The fse replaced with damaged connector and verified the equipment according to original equipment manufacturer's instructions.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively determined.Based on the results of the investigation, it is likely the connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: "accumulated stress over time which caused the connector to get loose.Unintentional impact to the connector with something hard." per the instructions for use: ¿check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.¿ and ¿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 device or facilities near the equipment.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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