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 blackout.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 remote control buttons cracked, the segment corroded, the ccd drive pcb corroded, the electrical pin connector corroded, the lg connector corroded, the bending rubber leak, the bending rubber cut, the insertion flexible tube twisted/buckled under and the root brace; 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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