The product complaint analysis team has completed its investigation of the device wjich was returned. The results of the investigation conducted by the appropriate enginneers and technicians are listed below. Visual inspection and results: evidence of debris in threaded ares, no; evidence of non-functionality, no; external damage to lcs/cs housing, no; external physical damage, no. Functional tests and results: blade not energize/cut correctly, no; lcs/cs jaw not open/close correctly, no; lcs/cs not rotate/latch correctly, no. Based on the information received and the visual and functional results, no conclusion could be reached as to what may have caused the reported incident. The device was received in good condition. The device was tested and was found to be functional. There were no anamolies noted with the alignment of the blade and tissue pad. The reported incident could not be recreated. Manufacturing and enginneering have been notified of the reported incident.

It was reported during a laparoscopic nissen fundoplication the staff couldn't get the lcs to properly align. The blade and the tissue pad would not come together properly. Another lcs was opened to complete the case. The alignment pin was in the grip housing unit, but has since vanished. They did have it inserted when introducing the blade. There was no consequence to the patient.