(b)(4).Batch # p93x3h.Investigation summary.The device was returned with the tissue pad damaged, melted and 100% present.The device was connected to a gen11 and the device did activate during functional testing.The device was disassembled to inspect the internal components and no anomalies were found related to the reported event.However, what was found was that there was a cracked internal component; the y-link.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when backcutting or while the blade is active, without tissue between the blade and tissue pad, to avoid damage to the tissue pad.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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