This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the biopsy inlet piece loosened.Based on the result, we concluded that it was caused due to the excessive force applied on the biopsy inlet piece.In addition, we confirmed that the operation channel buckled, and the insertion flexible tube (ift) buckled; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0620(control body)"" and/or the risk analysis results, it was evaluated to submit mdr.
|