E1: initial reporter address: (b)(6).E1: initial reporter postal code: (b)(6).H4: the lot was manufactured may 21, 2022 to june 02, 2022.The device was received for evaluation.The device was not returned in the original, unopened package.Visual inspection via the naked eye noted the fill pot cap was missing from the device.The reported condition was verified.The cause of the condition could not be determined; however, probable cause is use-related.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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