The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd signal wire broken.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd signal wire.In addition, our technician confirmed that the insertion flexible tube coating damage, the angle wire play, the distal body dirty, the nozzle gluing dirty, and the ccd module with drive pcb distorted image; 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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