The device was not returned for 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.
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It was reported during preparation of an xtw clip, one of the grippers would not fully lower.Troubleshooting was performed, including unlocking, locking, and extending the shaft, but the issue was unable to be resolved.Therefore, the clip was not used, discarded, and replaced.There was no clinically significant delay in the procedure.
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