This will be filed to report a single gripper actuation issue.It was reported that during device prep of a mitraclip procedure, one of the grippers failed to lower and the gripper line appeared to be broken.Subsequently, the clip was exchanged and the procedure was completed without further reported complication.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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All available information was investigated, and the reported gripper line break could not be confirmed via return device analysis.The reported difficult to open or close (gripper actuation - single) was confirmed due to the gripper line being caught on the frictional element (fe) of the gripper arm.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, the reported difficult to open or close (gripper actuation - single) was due to the gripper line being caught on the frictional element (fe).A cause of the observed mechanical jam, associated with gripper line being caught on fe, could not be determined.The reported gripper line break could not be identified through device analysis.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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