(b)(4).Date sent: 8/2/2023.D4: batch # a9ce9p.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b12srt device was received with the duckbill out of position and present.In addition, the duckbill was returned inside a plastic bag.No conclusion could be reached as to what might have caused the duckbill out of position.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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