The device was received for evaluation with an open pouch; an evaluation is complete.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection was performed with the naked eye.Functional testing was performed which included leak testing, clear passage testing, clamp function testing, and device-device interaction testing.The reported problem damaged was not verified because visual inspection was performed with no issues.The cause was undetermined.Should additional relevant information become available, a supplemental report will be submitted.
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