This device is not distributed in us so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the light emitting diode(led) blackout.Based on the result, we concluded that it was caused due to the excessive force applied on the light emitting diode(led).In addition, our technician confirmed that the aft suction tube buckled, the light guide cable cut, the pcb for cmos drive defective, and the insertion flexible tube bump; 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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