It was reported that during device preparation of a mitraclip xtw, one of the grippers did not lower all the way.The clip was locked and unlocked again, but the issue persisted.This was repeated several times according to troubleshooting guidelines.The clip was replaced and the procedure continued.There was no patient involvement, as the device was not entered into the anatomy.
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All available information was investigated, and the reported difficult to open or close (gripper actuation - single) could not be 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, a cause for the reported difficult to open or close (gripper actuation - single) could not be determined as the issue was not identified in device analysis.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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