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 light guide cable coating damage, the distal body broken, the control body broken, the air tube clogged, the air nozzle missing, the water nozzle missing, the insertion flexible tube crushed, the insertion flexible tube loose, the segment worn out, and the ccd module with drive pcb distorted 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.
|