Model Number A0393 |
Device Problem
Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.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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Event Description
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The customer reported to olympus that the hf-cable, monopolar sparked between the male connector that plugs into the generator and the cable.There was no report of patient harm or user injury associated with this event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
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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.Three attempts were performed to obtain additional information, but no response was received from the customer.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 reported event is unable to be determined.However, the cause of the event is likely due to wear and tear paired with improper handling of the.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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