This device is classified as import for export; therefore, 510k is not applicable.Model fb-15v is available in the usa with a 510k number: k951199.We checked the returned unit and confirmed that the image guide fiber bundle (cfb) was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the image guide fiber bundle (cfb).In addition, we confirmed that the insertion flexible tube (ift) worn out; however, it 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.
|