The device history record (dhr) was reviewed.No abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Per the provided information, a sample is available, but the device has not yet been received for evaluation therefore we were unable to perform functional and visual evaluations to confirm the reported issue or determine a root cause.However, a corrective and preventive action has been initiated to address the reported issue.Additionally, once the sample is received, the investigation will be reopened and updated further, if needed.
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