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

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.