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

Steven M. Lucas, Erik A. Pattison, Chandru P. Sundaram

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1222-1227
Number of pages6
JournalBJU International
Volume109
Issue number8
DOIs
StatePublished - Apr 2012

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Robotics
United States Food and Drug Administration
Equipment and Supplies
Wounds and Injuries
Databases

Keywords

  • Complications
  • Device failures
  • MAUDE database
  • Robotic surgery

ASJC Scopus subject areas

  • Urology

Cite this

Global robotic experience and the type of surgical system impact the types of robotic malfunctions and their clinical consequences : An FDA MAUDE review. / Lucas, Steven M.; Pattison, Erik A.; Sundaram, Chandru P.

In: BJU International, Vol. 109, No. 8, 04.2012, p. 1222-1227.

Research output: Contribution to journalArticle

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KW - Device failures

KW - MAUDE database

KW - Robotic surgery

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