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 biopsy inlet piece loose.Based on the result, we concluded that it was caused due to the excessive force applied on the biopsy inlet piece.In addition, our technician confirmed that the insertion flexible tube buckled, the u/d knob loose, the cfb (coherent fiber bundle) defective, and the insertion flexible tube collapse; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0620(control body)"" and/or the risk analysis results, it was evaluated to submit mdr.
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