(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report.Device history record review shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections were acceptable.Complaint cannot be confirmed as there is no device sample to evaluate at this time.If the device sample becomes available at a later date, this report will be updated with the evaluation results.
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