This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the ocular fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ocular.In addition, we confirmed that the control body fluid damage, the forward body frame fluid damage, the forward body cover fluid damage, the light source connector fluid damage, the aft suction tube fluid damage, the cfb screen cover glass fluid damage, the image guide fiber bundle (cfb) fluid damage, the operation channel perforated, the insertion flexible tube (ift) buckled, and the insertion flexible tube (ift) crushed; however, they are 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.
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