All available information was investigated and the reported actuator mandrel protruding from the l-lock tabs was 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 determined the reported issue is a normal function of the device as once the clip is deployed, the actuator coupler has been unthreaded from the clip which allows the actuator assembly to be advanced or retracted, which is an expected function of the device.In additions, once the coupler exited the l-lock tabs it would be very difficult or unable to retract it back into the l-lock.There is no indication of a product issue with respect to manufacture, design or labeling.
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