We checked the returned unit and confirmed that the operation channel stuck accessories and objects.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the operation channel.In addition, we confirmed that the light guide fiber bundle (lcb) broken, the insertion flexible tube (ift) buckled, the light guide cable buckled, the remote control buttons cracked, and the distal body worn out; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report "hr-rpt-0588(channel)" and/or the risk analysis results, it was evaluated to submit mdr.
|