The actual device was not available; however, a video and photographs of the sample were provided for evaluation.The returned video and photographs were reviewed, and it was noted that there was an external fluid leakage from an unspecified location.The reported condition was verified.The cause of the reported condition could not be determined.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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