The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the objective lens broken.Based on the result, we concluded that it was caused due to the excessive force applied on the objective lens.In addition, our technician confirmed that the lcb (light carrying bundle) broken, the ccd module with drive pcb cloudy (not clear view), the insertion flexible tube buckled, the remote control buttons leak, the light guide cable cut, the distal body worn out, the down pulley wire worn out, the up pulley wire worn out, the left pulley wire worn out, and the right pulley wire worn out; 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.
|