Per the evaluation findings the loop was broken off and not returned.The orange insulation was melted at the break and is bent in the middle.Additionally, there is black residue on the orange and yellow insulation.The ifu 97000002usca 02-2019, states " the product should not be manipulated or bent.Overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions".
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