This device is not distributed in us so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd module with drive pcb out of focus.Based on the result, we concluded that it was caused due to the moisture condensation in the ccd module with drive pcb.In addition, our technician confirmed that the light guide cable coating damage, the lcb (light carrying bundle) broken, the insertion flexible tube crushed, the u/d knob white marking faded/missing, and the u/d lock lever white marking faded/missing; 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.
|