The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cmos module with drive pcb objective lens cracked.Based on the result, we concluded that it was caused due to the excessive force applied on the cmos module with drive pcb.In addition, our technician confirmed that the insertion flexible tube coating damage, the insertion flexible tube buckled, the distal body melted, and the r/l knob white marking faded/missing; however, these defects 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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