The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the laser cut filter broken.Based on the result, we concluded that it was caused due to the excessive force applied on the laser cut filter.In addition, our technician confirmed that the lcb (light carrying bundle) broken, the lcb distal cover glass broken, the suction channel buckled, the objective lens scratched, the aft suction tube dirty, the insertion flexible tube worn out, the distal body worn out, the brand plate worn out, the light guide cable worn out, and the ccd module with drive pcb laser filter lifting; 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.
|