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 fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ccd module with drive pcb.In addition, our technician confirmed that the u/d knob broken, the u/d lock lever broken, the insertion flexible tube buckled, the light guide cable buckled, the light guide cable for control body buckled, the remote control buttons cracked, the insertion flexible tube crushed, the bending rubber leak, the control body leak, the remote control buttons leak, the bending rubber cut, and the remote control buttons cut; 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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