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 fluid damage from the cfb.In addition, we confirmed that the insertion flexible tube (ift) had fluid damage, the insertion flexible tube (ift) 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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