(b)(4).Additional information: the device was received for evaluation.Visual inspection (via the naked eye) revealed displaced protectors and malformed welding on the piston.Leakage was also noted.The reported problem was verified, however, the direct cause 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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