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 suction cylinder control body clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the suction cylinder control body.In addition, our technician confirmed that the ocular cover glass coating damage, the insertion flexible tube perforated, and the suction cylinder control body dirty; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0588(channel)"" and/or the risk analysis results, it was evaluated to submit mdr.
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