This device is class1 product so that 510k# is blank.We checked the returned unit and confirmed that the ccd module shadow in image.Based on the result, we concluded that it was caused due to the moisture condensation in the ccd module.In addition, we confirmed that the insertion flexible tube (ift) perforated, the light guide cable buckled, the remote control buttons cracked, and the insertion flexible tube (ift) leak; 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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