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 distal end with ccd module as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the distal end with ccd module.In addition, our technician confirmed that the insertion flexible tube fluid damage, the control body fluid damage, the ccd drive pcb fluid damage, the control body corroded, the lg connector corroded, the bending rubber missing, 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.
|