This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the bending rubber gluing as missing.Based on the result, we concluded that it was caused due to the excessive force applied on the bending rubber.In addition, we confirmed that the u/d lock knob lever broken, the ift buckled, the lg cable buckled, the suction arm deformed, the control body worn out, the biopsy inlet t-piece worn out, the lg cable connector worn out, the lg cable connector housing worn out and the u/d lock lever white marking faded; however, they are not the main cause, and/or irrelevant to the alleged complaint.Confirming pm in japan, in this case it could not be denied that the glue falls occurred in the human body.Therefore, based on the technical report ""hr-rpt-0581(bending rubber)"" and/or the risk analysis results, it was evaluated to submit mdr.
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