The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the operation channel (primary) accessory.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 segment compressed (short in length), the light guide cable buckled, and the insertion flexible tube crushed; 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.
|