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.
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It was reported that during device preparation of a mitraclip, the gripper line did not lower one of the grippers.Troubleshooting was performed and the clip was cycled twice in efforts to troubleshoot (cycling sequence: raised and lowered, locked and unlocked, and closed and reopened the clip twice in efforts to see if the gripper line would then lower).Troubleshooting did not lower the gripper.The device was removed and replaced from the preparation table.There was no contact with the patient and the device.
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