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 module with drive pcb broken.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 perforated; however, this defect is 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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