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 Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation.Upon evaluation the device presents error 433 (permanent reboot/temporary failure) repeatedly, restarting and blocking the device.The generator board was damaged.The reported issue was confirmed.In addition it was noted the top cover was deteriorated, and the volume knob is lacking on the back of the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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A user facility reported to olympus hf unit "esg-400" restarts continuously and displays error e433.There was no patient harm, no user injury reported due to the 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.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 was a defective generator board.There has since been a design change to prevent reoccurrence.A deeper investigation of generator boards with error e433 found a destroyed transformer tr1 to be the cause.An improved generator board was introduced into production on (b)(6) 2020 via change wcr-22681.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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