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 water jet tube clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the water jet tube.In addition, our technician confirmed that the lg water jet supply tubes deformed, and the bending rubber cut; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0630(air/water & jet water channels)"" and/or the risk analysis results, it was evaluated to submit mdr.
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