The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed, that the balloon feeder return tube clogged.Based on the result, we concluded that it was caused, due to the inadequate/insufficient reprocessing at the facility on the balloon feeder return tube.In addition, our technician confirmed, that the us connector casing broken, the insertion flexible tube compressed (short in length), the operation channel (primary) buckled, and the ultrasound connector body corroded.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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