We checked the returned unit and confirmed that the biopsy inlet piece loosened.Based on the result, we concluded that it was caused due to the excessive force applied on the biopsy inlet piece.In addition, we confirmed that the forward body frame cracked, the insertion flexible tube (ift) crushed, the angulation-down angulation decrease, and the angulation-up angulation decrease; 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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