This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cmos module with drive pcb signs of fluid droplets on the video image.Based on the result, we concluded that it was caused due to the moisture condensation in the cmos module with drive pcb.In addition, our technician confirmed that the insertion flexible tube coating damage, the distal body broken, the bending rubber worn out, and the u/d and the r/l pulley wires 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.
|