(b)(4).Batch # r9211k.Investigation summary: the device a 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.There were no alert screens displayed at any time during testing.When the device was disassembled to inspect the internal components, no anomalies were found related to the reported event.However, what was found was that there was a cracked internal component; the y-link.The ¿replace instrument¿ alert screen is displayed after receiving two consecutive alert screens and it is advising of a potential issue with the instrument.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 back cutting 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 there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.
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