This device is classified as import for export, therefore 510k is not applicable.Model fnl-10rp3 is available in the usa with a 510k number k951196.We checked the returned unit and confirmed that the image guide fiber bundle (cfb) improper adjustment.Based on the result, we concluded that it was caused due to the excessive force applied on the image guide fiber bundle (cfb).In addition, we confirmed that the bending rubber perforated, and the insertion flexible tube (ift) crushed; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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