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 biopsy inlet t-piece clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the biopsy inlet t-piece.In addition, our technician confirmed that the cfb (coherent fiber bundle) broken, the insertion flexible tube buckled, the suction cylinder control body clogged, the insertion flexible tube crushed, and the bending rubber dirty; 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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