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 on the biopsy inlet t-piece.In addition, we confirmed that the light guide fiber bundle (lcb) broken, the remote control buttons perforated, the light guide cable perforated, the insertion flexible tube (ift) buckled, the light guide cable buckled, the control body cracked, the light guide cable crushed, the objective lens unit dirty, and the distal body chipped; 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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