This device is not distributed in us so that 510k# is blank.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 forward body cover broken, the side body cover broken, the insertion flexible tube (ift) buckled, the insertion flexible tube (ift) crushed, and the ocular scratched ; 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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