title: Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study.
abstract: BACKGROUND
  Our goal was to analyze reported instances of the da Vinci robotic surgical system instrument failures using the FDA's MAUDE (Manufacturer and User Facility Device Experience) database. From these data we identified some root causes of failures as well as trends that may assist surgeons and users of the robotic technology.
  
  
  METHODS
  We conducted a survey of the MAUDE database and tallied robotic instrument failures that occurred between January 2009 and December 2010. We categorized failures into five main groups (cautery, shaft, wrist or tool tip, cable, and control housing) based on technical differences in instrument design and function.
  
  
  RESULTS
  A total of 565 instrument failures were documented through 528 reports. The majority of failures (285) were of the instrument's wrist or tool tip. Cautery problems comprised 174 failures, 76 were shaft failures, 29 were cable failures, and 7 were control housing failures. Of the reports, 10 had no discernible failure mode and 49 exhibited multiple failures.
  
  
  CONCLUSIONS
  The data show that a number of robotic instrument failures occurred in a short period of time. In reality, many instrument failures may go unreported, thus a true failure rate cannot be determined from these data. However, education of hospital administrators, operating room staff, surgeons, and patients should be incorporated into discussions regarding the introduction and utilization of robotic technology. We recommend institutions incorporate standard failure reporting policies so that the community of robotic surgery companies and surgeons can improve on existing technologies for optimal patient safety and outcomes.
authors.affiliation: Department of Electrical Engineering, University of Washington, 185 Stevens Way, Campus Box 352500, Seattle, WA 98195, USA. dwarden@uw.edu
authors.forename: Diana C W
authors.initials: DC
authors.lastname: Friedman
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Lendvay
authors.forename: Blake
authors.initials: B
authors.lastname: Hannaford
mesh_terms: D016208:Databases, Factual; D004559:Electric Wiring; D004564:Electrocoagulation / Q000295:instrumentation; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data; D006801:Humans; D010535:Laparoscopy / Q000295:instrumentation*; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D012308:Risk Management; D012371:Robotics / Q000295:instrumentation* / Q000706:statistics & numerical data; D015983:Selection Bias; D014481:United States; D014486:United States Food and Drug Administration