The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed, that the biopsy inlet t-piece broken accessory blocking inside biopsy t-piece.Based on the result, we concluded that it was caused, due to the excessive force applied on the biopsy inlet t-piece.In addition, our technician confirmed, that the distal body broken, the insertion flexible tube compressed (short in length), the operation channel (primary) buckled, the operation channel (primary) stuck accessory/object, and the side body cover leak.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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