This device is classified as import for export, therefore 510k is not applicable.Model eg-1690k 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 ccd module with drive pcb fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ccd module with drive pcb.In addition, our technician confirmed that the light guide cable coating damage, the segment broken, the remote control buttons perforated, the insertion flexible tube cut, the lg air/water socket cylinder dirty, the operation channel (primary) hole at distal body connection, and the ccd module with drive pcb laser filter lifting; 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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