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 cfb (coherent fiber bundle) broken.Based on the result, we concluded that it was caused due to the excessive force applied on the cfb (coherent fiber bundle).In addition, our technician confirmed that the segment fluid damage, the u/d pulley wire fluid damage, the left pulley wire fluid damage, the lcb (light carrying bundle) fluid damage, the objective lens broken, the suction channel buckled, the light guide cable for prong buckled, the control body corroded, the bending rubber missing, the air and the water nozzles missing, the objective gluing missing, the air tube leak, the water tube leak, the ocular dirty, the lcb distal cover glass dirty, the insertion flexible tube worn out, the distal body worn out, and the right pulley wire rupture; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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