The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the image shadow in image.Based on the result, we concluded that it was caused due to the moisture condensation in the image.In addition, our technician confirmed that the insertion flexible tube crushed, the bending rubber cut, and the light guide cable dented; 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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