Catalog Number 511100300060 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 the ring of 3.0mm coupler was misaligned.During an unspecified procedure, the "ring was not able to fully attach and failed to complete the anastomosis".There was no patient injury or medical intervention associated with this event.
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Manufacturer Narrative
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Correction made to e1: initial reporter city: (b)(6).Correction made to e1: initial reporter e-mail: (b)(6).H10: a device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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