Additional information was added to h3, h4 , h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph using the naked eye which revealed a black spot at the level of the clamp raw material.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the condition could not be determined, however, it was noted that the cause may be related to a raw material issue during the manufacturing process.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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