Model Number WB91051W |
Device Problems
Communication or Transmission Problem (2896); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 resetting continuously and producing an e433 error code.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence 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 device evaluation and investigation.Based on the results of the device evaluation, the reported event was confirmed along with burn traces.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to the ingress of moisture which led to damage/short circuitry of the generator board and motherboard.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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