This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the image guide fiber bundle (cfb) broken.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 insertion flexible tube (ift) crushed, and the segment crushed; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report "hr-rpt-0586(image failure)" and/or the risk analysis results, it was evaluated to submit mdr.
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