This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the cfb fluid damage.Based on the result, we concluded that it was caused due to the excessive force applied on the cfb.In addition, we confirmed that the bending rubber stretched, the insertion flexible tube (ift) crushed, the forward body cover was broken, the biopsy inlet piece missing, and the light guide fiber bundle (lcb) was broken; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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