The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The manufacturing site has received two cable sets for the evaluation.Under current mass production test conditions, the site has performed the electronic test on the returned cables, the two cable sets passed the electronic test.From the investigation, the returned cables are functional.Based on the dhrs review, no change of material, tooling, process procedure and machine parameter were noted.The site has performed 100% functional test; the reported issue cannot be caused by manufacturing process before shipment.At this time, a corrective and preventive action is not deemed necessary.
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