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.Based on available information, the cause of the reported unable to grasp leaflets was unable to be determined.The reported improper or incorrect procedure or method was associated with the use of the clip delivery system (cds) after it had expired.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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