Model Number WB91051W |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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To date, the device will not be returned to olympus for evaluation but an onsite investigation is underway.The investigation is ongoing and follow up with the user facility is currently being performed.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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Event Description
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The customer reported to olympus that the hf unit "esg-400" had an e433 error when starting the device.The issue was found during preparation for use and the procedure was completed with a similar device.There were no reports of patient harm.
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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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to a faulty high voltage power supply (hvps) board.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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