Catalog Number 511100250060 |
Device Problem
Device Dislodged or Dislocated (2923)
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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 a 2.5mm coupler fell out of the "u port"; anastomosis could not be completed.The issue was identified during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the coupler jaw assembly with the white protective holder was received for evaluation.Visual inspection was performed which observed that neither of the coupler rings were present in the jaw assembly (were not returned with the product).The reported condition was verified as the rings were not present in the device.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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