H4: the lot was manufactured on june 2021.H10: the actual device was not available; however, a photograph and video of the sample was provided for evaluation.Visual inspection was performed on the video and photograph which revealed an incorrect assembly issue.The reported condition was verified.The cause of the condition was due to a manual assembly issue during the manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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