Catalog Number 8000.COM03 |
Device Problem
Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The complain is under investigation.
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Event Description
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It was reported that during procedure, a burning smell was observed coming from machine.No actual patient harm or operator harm occurred.
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Event Description
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It was reported that during procedure, a burning smell was observed coming from machine.No actual patient harm or operator harm occurred.
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Manufacturer Narrative
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With regard to this an eva surgical system was inspected on location.During inspection performed the reported event could not be reproduced and the eva surgical system passed the final release test including the electrical safety test.Review of the complaint database indicated that no similar events have been logged on this surgical system until today.In addition, follow-up with the local application specialist indicated that the eva surgical system involved functions as anticipated without any issues since the date of the reported event.Furthermore, it was indicated that the site was unsure whether the burning smell was attributable to the eva system involved.Based upon the investigation results (i.E.No anomalies identified during functional inspection included an electrical safety test and other issues reported since time of occurrence) it is highly unlikely that the burning smell originated from the eva surgical system.Therefore, the reported event is not considered attributable to the eva surgical system involved.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.
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Search Alerts/Recalls
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