We checked the returned unit and confirmed that the balloon feeder/return tube clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the balloon feeder/return tube.In addition, we confirmed that the insertion flexible tube (ift) buckled, the insertion flexible tube (ift) crushed, and the us connector body loosened; 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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