This device is not distributed in us so that 510k#.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the biopsy inlet piece clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the biopsy inlet piece.In addition, our technician confirmed that the side body cover broken, the lcb (light carrying bundle) broken, the insertion flexible tube 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.
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