The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the biopsy inlet piece accessory.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the biopsy inlet piece.In addition, our technician confirmed that the insertion flexible tube compressed (short in length); however, this defect is 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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