The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd module with drive pcb cloudy not clear view.Based on the result, we concluded that it was caused due to the moisture condensation in the ccd module with drive pcb.In addition, our technician confirmed that the insertion flexible tube coating damage, the light guide cable for control body buckled, the lcb distal cover glass scratched, and the bending rubber dirty; 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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