Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.However, a supplier corrective action has already been opened to address the reported condition through a more robust investigation.In the meantime, all information received will be used for further tracking and trending purposes.
|