The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the angle wire broken.Based on the result, we concluded that it was caused due to the excessive force applied on the angle wire.In addition, our technician confirmed that the bending rubber leak, the remote control buttons leak, the bending rubber cut, the remote control buttons cut, and the distal body worn out; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, no response was obtained, so we cannot deny the possibility of the angle stuck.Therefore, based on the technical report ""hr-rpt-0587(angle)"" and/or the risk analysis results, it was evaluated to submit mdr.
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Additional information as a result of investigation in pentax medical america on february 21, 2024, it was found that the angulation was not stuck in j-position.Based on the result, we have re-evaluated the decision tree and determined that this event is not reportable.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
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