Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.The samples returned was received inside of a plastic bag which is not its original packaging.Visual inspection results: no damages or other defects were detected on the sample.Is observed that the blue clip is not present on both samples.Functional testing results: no discrepancies were detected on the sample the test successfully passed the test - the failure mode reported is not confirmed.The customer stated problem was not duplicated.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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