Global robotic experience and the type of surgical system impact the types of robotic malfunctions and their clinical consequences: An FDA MAUDE review

摘要

OBJECTIVES: ? To assess annual rates of robotic system malfunctions and compare the da Vinci S? system (dVS) and da Vinci? surgical system (dV). ? To assess the types of malfunctions and associated outcomes for robotic cases and determine the extent to which experience and technological improvements impact these. PATIENTS AND METHODS: ? This study is a retrospective review of the US Food and Drug Administration (FDA) MAUDE (Manufacturer and User Facility Device Experience) database, a publicly available, voluntary reporting system (http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfmaude/search.cfm). ? The database was searched using the two phrases 'da Vinci' and 'Intuitive Surgical' from 2003 to 2009. ? Malfunctions of the instruments, console, patient-side cart, camera and cannula were recorded. ? Data on intraoperative injuries, case delays and conversions were also collected. RESULTS: ? In all, 1914 reports were reviewed (991 dVS and 878 dV, 45 unclassified) with peak years for reports of 2008 for dVS (571) and 2007 for dV (211), P < 0.001. ? With respect to time, the proportion of console and patient-side cart malfunctions declined from 2007 onward compared with the proportions prior to 2007 (5.1% vs 9.4% and 6.6% vs 10.9%). ? Patient injury did not change with year of surgery (0.5-5.4% of malfunctions, P = 0.358), open conversions declined (21.3% of malfunctions before 2007 vs 9.9% from 2007 onward, P < 0.001) and patient deaths increased (0.0013% of cases before 2007 vs 0.0061% of cases from 2007 onward, P < 0.001). ? With regard to robotic system, console and patient-side cart malfunctions were more frequent with the dV than the dVS: 82/878 vs 39/991 and 100/878 vs 48/991, P < 0.001. ? Open conversion was more frequent with dV than dVS (19.3% vs 7.7% of reported malfunctions, P < 0.001), while patient injury was less with dV than dVS (3.5% vs 5.9%, P = 0.021). CONCLUSIONS: ? The dVS decreased console and patient-side cart errors relative to total malfunctions, which were also influenced by surgical year. ? Open conversions were reduced by increased robotic experience and newer surgical system. ? Differences in patient injury may reflect changes in reporting or case complexity.