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Specific Risks Related to Robotic Surgery: Are They Real?

  • Luca Moraldi
  • Giuseppe Barbato
  • Andrea Coratti
Conference paper
Part of the Advances in Intelligent Systems and Computing book series (AISC, volume 818)

Abstract

Robotic surgery, in recent years, has had an exponential increase, both as a number of procedures and as new indications to a robotic surgical approach. With the massive use of the robotic approach in surgery, the safety of this device and monitoring of any malfunctions play an increasingly important role. The goal of this literature review is to analyze different causes of unexpected complications or potential errors in the Da Vinci system, to increase patient and operator safety in the future. The complication rate directly related to robotic malfunction is very low, approximately from 0,02% to 4,97%. Splitting the data across studies MAUDE based and single or multi center experience will notice immediately that the rate is lowest among the MAUDE based (from 0,02% to 0,61% vs from 2,39% to 4,97%). Malfunctions are uncommon and the need to abort or convert to another modality is rare. Most importantly, while mechanical and electronic errors can happen, they do not appear to impact surgical outcomes or patient safety.

Keywords

Robotic surgery Da Vinci system Malfunctions 

References

  1. 1.
    Hussain A, Malik A, Halim MU, Ali AM (2014) The use of robotics in surgery: a review. Int J Clin Pract 68(11):1376–1382CrossRefGoogle Scholar
  2. 2.
  3. 3.
    MAUDE: Manufacturer and User Facility Device Experience. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
  4. 4.
    Gurtcheff SE (2008) Introduction to the MAUDE database. Clin Obstet Gynecol 51(1):120–123.  https://doi.org/10.1097/GRF.0b013e318161e657CrossRefGoogle Scholar
  5. 5.
    Rajih E (2017) Error reporting from the da Vinci surgical system in robotic surgery: a Canadian multispecialty experience at a single academic centre. Can Urol Assoc J 11(5):E197CrossRefGoogle Scholar
  6. 6.
    Gupta P (2017) Development of a classification scheme for examining adverse events associated with medical devices, specifically the DaVinci surgical system as reported in the FDA MAUDE database. J Endourol 31(1):27–31MathSciNetCrossRefGoogle Scholar
  7. 7.
    Alemzadeh H, Raman J, Leveson N, Kalbarczy Z (2016) Adverse events in robotic surgery: a retrospective study of 14 years of FDA. PLoS ONE 11(4):e0151470CrossRefGoogle Scholar
  8. 8.
    Agcaoglu O (2012) Malfunction and failure of robotic systems during general surgical procedures. Surg Endosc 26(12):3580–3583CrossRefGoogle Scholar
  9. 9.
    Talamini M (2002) Robotic gastrointestinal surgery: early experience and system description. J Laparoendosc Adv Surg Tech Videosc 12(4):225–232CrossRefGoogle Scholar
  10. 10.
    Kim WT (2009) Failure and malfunction of da Vinci surgical systems during various robotic surgeries: experience from six departments at a single institute. Laparosc RobotGoogle Scholar
  11. 11.
    Chen CC (2012) Malfunction of the da Vinci robotic system in urology. Int J Urol.  https://doi.org/10.1111/j.1442-2042.2012.03010.xCrossRefGoogle Scholar
  12. 12.
    Lucas SM, Pattison E, Sundaram CP (2012) Global robotic experience and the type of surgical system impact the types of robotic malfunctions and their clinical consequences. An FDA MAUDE review. BJU Int 109(8):1222–1227CrossRefGoogle Scholar
  13. 13.
    Cooper M, Ibrahim A, Lyu H, Makary MA (2015) Underreporting of robotic surgery complications. J Health Qual 37(2):133–138CrossRefGoogle Scholar
  14. 14.
    Andonian S (2008) Device failures associated with patient injuries during robot-assisted laparoscopic surgeries: a comprehensive review of FDA MAUDE database. Can J Urol 15(1):3912–3916Google Scholar
  15. 15.
    Dubeck D (2014) Robotic-assisted surgery: focus on training and credentialing. PA Patient Saf Advis 11(3):93–101Google Scholar
  16. 16.
    Catchpole KR (2018) Diagnosing barriers to safety and efficiency in robotic surgery. Ergonomics 61(1):26–39CrossRefGoogle Scholar
  17. 17.
    Ashwin N (2017) Sridhar training in robotic surgery—an overview. Urosurg Curr Urol Rep 18:58.  https://doi.org/10.1007/s11934-017-0710-yCrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Luca Moraldi
    • 1
  • Giuseppe Barbato
    • 1
  • Andrea Coratti
    • 1
  1. 1.Azienda Ospedaliero-Universitaria CareggiFlorenceItaly

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