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 channel blocked.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the suction channel.In addition, our technician confirmed that the air nozzle clogged, and the remote control buttons cut; 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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