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 ocular fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ocular.In addition, our technician confirmed that the control body fluid damage, the forward body frame fluid damage, the cfb screen cover glass fluid damage, the cfb (coherent fiber bundle) fluid damage, the insertion flexible tube perforated, the insertion flexible tube crushed, 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-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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