We checked the returned unit and confirmed that the biopsy inlet t-piece clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the insertion flexible tube (ift) perforated, the light guide cable for prong perforated, and the suction cylinder control body clogged; 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.
|