This device is classified as import for export, therefore 510k is not applicable.Model eg-2990k is available in the usa with a 510k number k131902.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the air tube clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the air tube.In addition, our technician confirmed that the down pulley wire fluid damage, the up pulley wire fluid damage, the left pulley wire fluid damage, the right pulley wire fluid damage, the ccd module with drive pcb fluid damage, the lcb (light carrying bundle) fluid damage, the water tube clogged, the operation channel (primary) leak, the bending rubber leak, and the angle wire 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-0630(air/water & jet water channels)"" and/or the risk analysis results, it was evaluated to submit mdr.
|