This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the ccd module noise.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the light guide cable buckled, the insertion flexible tube (ift) cut, and the insertion flexible tube (ift) spiral closer condition; 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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