Model Number WB91051W |
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 10/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
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Event Description
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The customer reported that his olympus hf generator unit was displaying an e433 error code during use.There was no patient harm reported as a result of 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 investigation and correction to d9, h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The service department confirmed this error.Based on the results of the investigation, the root cause of the e433 error code traces it back to the faulty generator board.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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