論達文西輔助手術損害及其預防和司法處理

On Prevention of Da Vinci Assistied Surgery Injury and Its Judicial Treatment

研究達文西輔助手術損害及其預防和司法處理，可提升患者安全水準，也可用於發展手術機器人技術和產業。達文西輔助手術決策及其實施，手術損害的司法處理，須周密考慮可能影響患者安全的各種因素。達文西手術機器人是美國技術，本文首先應用其本土案例和數據，解析達文西輔助手術損傷類型，從預防的角度，分析可能導致患者損傷的操作者因素、製造者因素、裝備者因素、患者因素和其他因素。在此基礎上，運用中美兩國案例，討論相關的主要法律問題和爭議焦點。然後，圍繞達文西輔助手術安全問題，從手術機器人臨床應用倫理的角度，從ISI確認的使命出發，綜合運用中美兩國學者的觀點，分析患者與廠商、廠商與醫生、患者與醫院、患者與醫師、醫院與醫師、廠商與醫院，這樣六對倫理關係，分別探討有關倫理規則。中國大陸相關司法案例顯示，這種探討具有很強的必要性和啟示意義，提示業內人士開展達文西輔助手術，應注意有嚴格的適應症、損傷表現遲發但後果嚴重、警惕原因不明的損害、重視達文西產品責任。針對發現的問題，提出七點建議。

Studying the injuries caused by Da Vinci assisted surgery and its prevention and judicial treatment can improve the safety level of patients, and can also be used to develop the technology and industry of surgical robot. Da Vinci assisted surgical decision-making and implementation, as well as judicial treatment of surgical injuries, must carefully consider various factors that may affect patient safety. Da Vinci surgical robot is an American technology, so this paper first applies its local cases and data analyzing the types of injuries caused by Da Vinci assisted surgery, and probing the operator factors, manufacturer factors, equipper factors, patient factors and other factors that may cause personal injuries to patients from the perspective of prevention. On this basis, discuss the main legal issues and the focus of disputes related by using the cases of China and the United States. Then, starting with the ISI’s stated mission, by comprehensively appling the views of Chinese and American scholars, the six ethical relationships between patients and manufacturer, between manufacturer and doctors, between patients and hospitals, between patients and doctors, between hospitals and doctors, between manufacturer and hospitals, are analyzed from the perspective of ethics of clinical application of surgical robot, and relevant ethical rules are discussed respectively by focusing on the safety of da Vinci’s assisted surgery. The relevant judicial cases in China show that this discussion is of great necessity and enlightenment, suggesting that professionals in the industry should pay attention to the strict indications, the delayed injuries performance, the alert to the damage of unknown causes, and the responsibility of Da Vinci products when carrying out Da Vinci assisted surgery. Seven suggestions are put forward for the problems found.