This device is classified as import for export, therefore 510k is not applicable.Model eb-1575k is available in the usa with a 510k number k131028.We checked the returned unit and confirmed the ccd driver pcb as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd driver pcb.In addition, we confirmed that the insertion flexible tube (ift) buckled, the segment crushed, the light guide fiber bundle (lcb) broken, the remote control buttons cut, and the light guide cable buckled; 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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