855 ADVERSE EVENTS ASSOCIATED WITH THE DAVINCI SURGICAL SYSTEM AS REPORTED IN THE FDA MAUDE DATABASE

摘要

You have accessJournal of UrologyTechnology & Instruments: Robotics: Benign & Malignant Disease (I)1 Apr 2013855 ADVERSE EVENTS ASSOCIATED WITH THE DAVINCI SURGICAL SYSTEM AS REPORTED IN THE FDA MAUDE DATABASE Priyanka Gupta, John Schomburg, Erik Lund, Olukawayode Adejoro, and Badrinath Konety Priyanka GuptaPriyanka Gupta Minneapolis, MN More articles by this author , John SchomburgJohn Schomburg Minneapolis, MN More articles by this author , Erik LundErik Lund Madison, WI More articles by this author , Olukawayode AdejoroOlukawayode Adejoro Minneapolis, MN More articles by this author , and Badrinath KonetyBadrinath Konety Minneapolis, MN More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.423AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The introduction of robotic technology has rapidly gained popularity since it was first described for a robotic-assisted laparoscopic radical prostatectomy in 2001. Our study examines the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE) for adverse events associated with the DaVinci Surgical System between the years 2009-10. METHODS The MAUDE database was searched using the terms “robot,” “DaVinci,” and “Intuitive Surgical” for the years 2009-10. A total of 741 events were identified. Events were grouped by category of surgery performed (urology, ob/gyn, other, not specified) and device used (energy instrument, endowrist, instrument accessory, surgical system, other). A classification system was developed to associate a level of severity with each event and its relationship to the DaVinci Surgical System. RESULTS Of the 741 cases examined 27.3% were Urology cases, 32.6% Ob/Gyn, 10.80 other, and 29.2% were not specified. The majority of events were associated with the use of an energy instrument (43.45%), 19.30% were associated with the surgical system, and 11.67% with an instrument accessory. A significant difference was found in the severity of events observed than would be expected by chance for the type of device used (p <.0001, Fischer's exact test), the category of surgery performed (p <.0001, Fischer's exact test) and their relationship to the DaVinci Surgical System (p <.0001, Fischer's exact test). CONCLUSIONS Overall the number of adverse events with the DaVinci Surgical System remains low, approximately 0.1% over 2 years. From our analysis of the FDA MAUDE database we determined that the type of surgery performed and device used with the DaVinci Surgical System is related to the severity of associated adverse events. As practitioners continue to use the DaVinci Surgical System more routinely it is important to counsel patients regarding possible device malfunctions that can occur. Severity of Event Classification Mild No harm occurring to patient or staff. No significant deviation from planned procedure. Moderate Harm to patient or staff requiring minor intervention. Deviation from planned procedure without change in surgical outcome. Severe Harm to patient requiring major intervention. Significant intra-operative deviation from planned procedure requiring aggressive intervention. Life-threatening/Death Life-threatening event or death during procedure. Relationship of Event to Device Description Not Related Clearly unrelated event, adverse event related to pt's baseline health or surgeon's or user's error Possibly Event may be related to device but not some ambiguity remains Definitely Event is clearly related to device malfunctioning, examples include system error causing case to be aborted or device breaking causing need to switch instruments or retrieve parts © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e351 Advertisement Copyright & Permissions© 2013 by American Urological Association Education a