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 u/d knob broken, the lcb (light carrying bundle) broken, the insertion flexible tube crushed, the biopsy inlet barrel deformed, the biopsy inlet piece deformed, the biopsy inlet t-piece deformed, and the ethylene oxide gas valve (eog) loose; 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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