This device is not distributed in us.We checked the returned unit and confirmed that the operation channel 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) buckled and the biopsy inlet t-piece clogged, 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 and/or the risk analysis results, it was evaluated to submit mdr.
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