Catalog Number 8000.COM05 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.
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Event Description
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We have been informed during procedure the pedal stopped working.No actual patient harm occured.Surgery was prolonged > 30 minutes.
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Manufacturer Narrative
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In regard to this complaint, logfiles and pictures were provided for review.Review of the logfiles revealed multiple fop65541 error messages, indicating an undefined horizontal position of the main pedal.It was advised to set the turning knob to the middle to see if it solves the problem.Based on review of the available information, it was determined that the reported complaint most likely is attributable to a sensor issue.However, it cannot be confirmed conclusively as the pedal was not returned to d.O.R.C for investigation.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.All similar incidents related to the eva surgical system are included in the analysis (all failure modes including error code fop65541).Since 2020 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that a fop65541 error message will not always lead to a prolonged surgery.
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Event Description
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We have been informed during procedure the pedal stopped working.No actual patient harm occured.Surgery was prolonged > 30 minutes.
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Search Alerts/Recalls
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