This device is classified as import for export, therefore 510k is not applicable.Model fb-18v is available in the usa with a 510k number k951199.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the operation channel (primary) blocked.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the operation channel (primary).In addition, our technician confirmed that the light guide cable coating damage, the insertion flexible tube compressed (short in length), the control body corroded, and the segment hard to move; however, these defects 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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