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 operation channel (primary) stuck accessory/object.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the operation channel (primary).In addition, our technician confirmed that the insertion flexible tube buckled, the bending rubber dirty, the segment hard to move, the down pulley wire disconnected pulley wire collar, the up pulley wire disconnected pulley wire collar, and the remote control buttons misconfigured; 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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