The device was received for evaluation.A visual inspection was made and it was observed that the sample was correctly assembled and packed according to local specifications.Additionally, the lower clamp was absent.The reported condition was verified.The cause of the condition was related to human production during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
|