Catalog Number CDS0702-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 02/13/2024 |
Event Type
malfunction
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Event Description
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It was reported that during preparation of a mitraclip xtw, one of the grippers did not raise.Troubleshooting was performed but was not successful.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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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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N/a.
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Manufacturer Narrative
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All available information was investigated and the reported gripper actuation issue was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported gripper actuation issue.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.
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Search Alerts/Recalls
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