The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cfb (coherent fiber bundle) was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the cfb (coherent fiber bundle).In addition, our technician confirmed that the lcb (light carrying bundle) broken, the segment compressed (short in length), the operation channel (primary) 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-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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