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Catalog Number ASKU |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that there was an event when a gem flowcoupler failed to detect compromised anastomotic patency during a surgical procedure on a patient.This was further described by the surgeon as ¿had a case of false positive for flow on a buried flap, picked up signal from adjacent vessel flow¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Search Alerts/Recalls
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