Model Number CD-B620LA |
Device Problems
Energy Output Problem (1431); No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned for evaluation, the user facility discarded the device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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It was reported during an unspecified procedure, when the device was activated, there was no output.The user connected a second like device and the unit work normally.There was no patient harm or injury reported associated on this reported event.No user injury reported.
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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 and correction.Corrected initial reporters information to 'non-healthcare professional'.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, no output from the device was likely from a possible interference with the frequency or potential disconnect between components.The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user¿s experience cannot be determined at this time.The following is included in the instructions for use: "interference produced by the operation of high frequency surgical equipment may influence the operation of other electrical equipment adversely.Refer to the generator user manual." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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