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 ccd drive pcb as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd drive pcb.In addition, our technician confirmed that the operation channel (primary) buckled, the water jet tube buckled, the insertion flexible tube buckled, the insertion flexible tube worn out, and the ccd module with drive pcb shadow in image; 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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