This device is classified as import for export, therefore 510k is not applicable.Model vnl11-j10 is available in the usa with a 510k number k172156.We checked the returned unit and confirmed that the insertion flexible tube(ift) spiral closer condition.Based on the result, we concluded that it was caused due to the excessive force applied on the insertion flexible tube.In addition, we confirmed that the u/d knob broken, the remote control buttons perforated, the insertion flexible tube (ift) buckled, the light guide cable for control body crushed, the remote control buttons leak, and the remote control buttons worn out; however, they are not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, no response was obtained, so we can not deny the possibility of the angle stuck.Therefore, based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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