Catalog Number CDS0705-XTW |
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 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during preparation of the clip delivery system (cds), one of the grippers was unable to lower.Therefore, the clip was not used and was replaced.There was no clinically significant delay in the procedure.
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Manufacturer Narrative
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Returned device analysis did not confirm the reported single gripper actuation issue (difficult to open or close).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history did not indicate a lot-specific product issue.Based on information provided and the results of the returned device analysis (unable to confirm the reported issue), a cause for the reported difficult to open or close associated with a single gripper actuation issue during device preparation could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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