(b)(4).Batch #t93h00.Device analysis: the device was returned with the blade scratched and cracked.Additionally, the tissue pad was damaged, melted, and 100% present.In addition, the tissue pad was attached to the clamp arm and not detached as reported by the customer.During functional testing on gen11, an alert screen was displayed.The blade broke off during functional testing.The device was disassembled to inspect the internal components and no anomalies were found.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result include "remove instrument from patient," ¿blade error detected¿ or "relaxed pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.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.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.
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It was reported that during a pancreatectomy, at the beginning of the surgery, the tissue pad of the device detached and stopped working, there was no major problem with the patient or in the surgery for this failure.There were no patient consequences reported.
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