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 02/29/2024 |
Event Type
malfunction
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Event Description
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It was reported that during preparation, one gripper did not lower.Troubleshooting was performed, but the issue was unable to be resolved.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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Manufacturer Narrative
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All available information was investigated, and the reported single 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.Based on available information and the returned device analysis, the cause of the reported single gripper actuation issue was unable to be determined.
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Search Alerts/Recalls
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