The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd 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 ccd module with drive pcb.In addition, our technician confirmed that the distal body broken, the lcb distal cover glass broken, the operation channel (primary) perforated, the light guide cable buckled, the suction channel buckled, the insertion flexible tube cut, the remote control buttons cut, the u/d and the r/l pulley wires worn out, and the brand plate worn out; 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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