Model Number WB91051W |
Device Problem
Intermittent Loss of Power (4016)
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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 been returned to olympus for evaluation and repair.The evaluation has not been completed at this time.The investigation is ongoing, and the 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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Event Description
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It was reported by olympus technician that during maintenance, the hf unit "esg-400 had an error code e433.There was no patient harm or user injury reported due to the event.
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Manufacturer Narrative
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The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.Updates to section h4 and h6.Additionally, a correction to h3 is being made since the device evaluation was not able to be completed.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.Error e433 is triggered by the safety system of the esg-400 and results in a restart of the generator.If the cause of the error remains, there may be an unlimited number of periodic restarts.The following causes are possible: the user activates the foot switch while the generator is booting, a faulty foot switch, a defective cable connection, or a defective circuit board.Olympus will continue to monitor the field performance of this device.
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Manufacturer Narrative
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The device was returned for evaluation.The evaluation confirmed the reported e433 error message causing the generators to keep turning off and back on again which was due to a faulty generator board.Additionally, the overlay sticker was missing.The faulty parts were replaced.The device was inspected and passed olympus functional standards.
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Search Alerts/Recalls
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