Model Number WB91051W |
Device Problems
Crack (1135); 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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Event Description
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The customer reported to olympus that the hf unit "esg-400" had a startup problem.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: there was an e433 error log as the power switch is worn and would not stay in the on position.The generator board was old, the front panel and touchscreen damaged and cracked as well.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: there was an e433 error log as the power switch is worn and would not stay in the on position.The generator board was old, the front panel and touchscreen damaged and cracked as well.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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 of the event could not be determined although it can be presumed it was due to a defective component on the generator board.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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