This device is not distributed in us so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cfb (coherent fiber bundle) 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 control body fluid damage, the forward body frame fluid damage, the light source connector fluid damage, the ocular fluid damage, the cfb screen cover glass fluid damage, the cfb (coherent fiber bundle) fluid damage, the forward body cover broken, the side body cover broken, the lcb (light carrying bundle) broken, the bending rubber perforated, the insertion flexible tube crushed, the segment crushed, the bending rubber dirty, and the operation channel (primary) resistance; 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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