This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the cfb image failure.Based on the result, we concluded that it was caused due to the excessive force applied on the cfb.In addition, we confirmed that the insertion flexible tube (ift) leakage, the insertion flexible tube (ift) cut, the segment hard to move, and the control body dirty; 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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