The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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A review of the device history record could not be reviewed because there was no serial number provided by the customer.There were no samples provided for evaluation, however a photograph was submitted for evaluation.The reported condition can be observed in the photo however, quality specifications and compliance of the product could not be determined from the photo alone; a physical sample is required to perform a thorough inspection of the device.The reported condition could not be confirmed based solely on the photograph.The reported condition could not be confirmed to be manufacturing related therefore no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.
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