Model Number 12-80-10 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/15/2020 |
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 (b)(4) received a report that a electrical venous occluder (evo) displayed an error code associted to the encoder during procedure.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: the device was returned to the manufacturer site for repair and the problem was traced back to a defective hvb circuit board.The part was replaced and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Search Alerts/Recalls
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