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 stuck object inside t-piece.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the u/d knob broken, the light guide cable buckled, and the insertion flexible tube (ift) spiral closer condition; 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.
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