(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number (b)(4).The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Investigation conclusion: our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Root cause description: based on the investigation results, an exact cause for this incident could not be identified.Rationale: further action has not been determined necessary at this time.
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