Model Number 12-80-10 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova received report that a electrical venous occluder (evo) gave an error code associated to the clamp encoder during priming and the error could not be cleared.There was no patient involvement.
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Manufacturer Narrative
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H.10: the affected device was returned to manufacturer site for repair.The reported issue could not be reproduced upon testing.However, the ribbon cable and the encoder have been replaced as potentially involved components.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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See initial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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Based on troubleshooting results and investigation for similar cases, the most likely root cause of the reported issue is an intermittent faulty connection between the encoder and the ribbon cable which have been replaced.
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Search Alerts/Recalls
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