Model Number WB91051W |
Device Problems
Electrical /Electronic Property Problem (1198); Loss of Power (1475)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2022 |
Event Type
malfunction
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Event Description
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An olympus field representative was informed that the olympus, model wb91051w, hf unit "esg-400," generated an error "e433." there was no patient injury, associated with the problem, reported to olympus.
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Manufacturer Narrative
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The suspect device was returned to olympus.An evaluation has not been completed at this time.The investigation is ongoing and the 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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Manufacturer Narrative
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This supplemental report is submitted to provide additional event related information.
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Event Description
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The problem, as reported to olympus, was identified during a device inspection.There was no patient involvement, associated with the event, reported to olympus.An additional problem was reported that the device turned off while it was turning on.
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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.Approximately almost 3 years have passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, the reported phenomenon was likely caused due to a defective module.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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