The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the laser cut filter broken.Based on the result, we concluded that it was caused due to the excessive force applied on the laser cut filter.In addition, our technician confirmed that the operation channel (primary) buckled, the insertion flexible tube buckled, the light guide cable buckled, and the objective gluing missing; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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