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 light guide cable coating damage, the insertion flexible tube crushed, the light guide cable crushed, the light guide cable for control body disinfections damage, the light guide cable for prong disinfections damage, the ccd module with drive pcb defective, and the insertion flexible tube twisted; 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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