Catalog Number 511100250060 |
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 09/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).The devices were 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 the ring of two (2) 2.5mm couplers were unable to fully attach.This issue was identified during patient surgery.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 two (2) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was also performed and no issue were noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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