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 distal end with ccd module fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the distal end with ccd module.In addition, our technician confirmed that the control body fluid damage, the light guide cable coating damage, the lcb (light carrying bundle) broken, the insertion flexible tube perforated, the insertion flexible tube crushed, the lg prong top loose, the operation channel (primary) resistance, the root brace rubber (insertion flexible tube) discolored, and the u/d knob 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.
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