This device is classified as import for export, therefore 510k is not applicable.Model eb15-j10 is available in the usa with a 510k number k200678.We checked the returned unit and confirmed that the biopsy inlet t-piece broken accessory blocking inside biopsy t-piece.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the biopsy inlet t-piece.In addition, we confirmed that the insertion flexible tube (ift) dented; however, it is 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.
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