This device is class1 product so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd module with drive pcb over saturation.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 u/d lock lever broken, the remote control buttons cracked, and the remote control buttons leak; 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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