Surgical Endoscopy

, Volume 33, Issue 3, pp 717–723 | Cite as

Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies

  • James J. JungEmail author
  • Arash Kashfi
  • Sahil Sharma
  • Teodor Grantcharov



The burden of device-related interruptions is expected to increase as modern surgical practices adopt complex minimally invasive surgery devices. Currently, there is a paucity of empiric data that examined the nature of device-related interruptions using comprehensive intraoperative data.


We performed a cross-sectional study of consecutive elective laparoscopic general surgery cases performed in one operating room (OR) at a referral center between April 2014 and April 2016. The included cases were directly observed using a comprehensive multiport data recorder called the OR Black Box. The data were synchronized, encrypted, and reviewed by expert surgeon assessors. The assessors characterized device-related interruptions that occurred during operations. The prevalence of the cases with device-related interruptions was calculated. Device-related interruptions were classified into a priori categories of (1) absent/wrong device; (2) improper assembly; (3) loss of sterility; (4) disconnection; and (5) device failure.


In a cohort of 210 cases, 64 (30%) had at least one device-related interruption. Sleeve gastrectomy (52%) and oncologic gastrectomy (43%) procedures experienced the highest prevalence of device-related interruptions. Device failure was the most frequently chosen category with laparoscopic staplers implicated in more than half of these failures. Three failure modes were described for laparoscopic stapler, of which stapler malfunction (46%) was the most common.


Device-related interruptions occurred frequently in the OR and could be characterized into one of the five categories. Understanding the nature of the device-related interruptions can help guide implementation of safety interventions and user training in the future.


Surgical safety Education Interruption Distraction Surgery 



This study was supported by Ethicon Canada, Medtronic Canada, Olympus Canada, Baxter Canada, Takeda Canada and Intuitive Surgical (US).

Compliance with ethical standards


Teodor Grantcharov holds intellectual property ownership of Surgical Safety Technologies Inc. and is supported by research grants from Medtronic Canada, Ethicon Canada, Baxter Canada, Olympus Canada, Takeda Canada, and Intuitive Surgical. James J. Jung and Arash Kashfi and Sahil Sharma have no conflicts of interest or financial ties to disclose.


  1. 1.
    Kohn LT, Corrigan JM, Donaldson MS (2000) To err is human: building a safer health system. National Academies Press (US), Washington, DCGoogle Scholar
  2. 2.
    Leape LL, Berwick DM (2005) Five years after to err is human: what have we learned? JAMA 293:2384–2390CrossRefGoogle Scholar
  3. 3.
    Sexton JB, Thomas EJ, Helmreich RL (2000) Error, stress, and teamwork in medicine and aviation: cross sectional surveys. BMJ 320:745–749. CrossRefGoogle Scholar
  4. 4.
    Helmreich RL, Merritt AC, Wilhelm JA (1999) The evolution of crew resource management training in commercial aviation. Int J Aviat Psychol 9:19–32CrossRefGoogle Scholar
  5. 5.
    Barach P, Small SD (2000) Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 320:759–763. CrossRefGoogle Scholar
  6. 6.
    Wiegmann DA, ElBardissi AW, Dearani JA, Daly RC, Sundt TM (2007) Disruptions in surgical flow and their relationship to surgical errors: an exploratory investigation. Surgery 142:658–665. CrossRefGoogle Scholar
  7. 7.
    Sevdalis N, Undre S, McDermott J, Giddie J, Diner L, Smith G (2014) Impact of intraoperative distractions on patient safety: a prospective descriptive study using validated instruments. World J Surg 38:751–758. CrossRefGoogle Scholar
  8. 8.
    Healey AN, Primus CP, Koutantji M (2007) Quantifying distraction and interruption in urological surgery. Qual Saf Health Care 16:135–139. CrossRefGoogle Scholar
  9. 9.
    Arora S, Hull L, Sevdalis N, Tierney T, Nestel D, Woloshynowych M, Darzi A, Kneebone R (2010) Factors compromising safety in surgery: stressful events in the operating room. Am J Surg 199:60–65. CrossRefGoogle Scholar
  10. 10.
    Feuerbacher RL, Funk KH, Spight DH, Diggs BS, Hunter JG (2012) Realistic distractions and interruptions that impair simulated surgical performance by novice surgeons. Arch Surg 147:1026. CrossRefGoogle Scholar
  11. 11.
    Blikkendaal MD, Driessen SRC, Rodrigues SP, Rhemrev JPT, Smeets MJGH, Dankelman J, van den Dobbelsteen JJ, Jansen FW (2017) Surgical flow disturbances in dedicated minimally invasive surgery suites: an observational study to assess its supposed superiority over conventional suites. Surg Endosc 31:288–298. CrossRefGoogle Scholar
  12. 12.
    Duff SN, Windham TC, Wiegmann DA, Kring J, Schaus JD, Malony R, Boquet A (2010) Identification and classification of flow disruptions in the operating room during two types of general surgery procedures. In: Proceedings of the Human Factors and Ergonomics Society annual meeting. SAGE Publications Sage CA, Los Angeles, pp 884–888Google Scholar
  13. 13.
    Healey AN, Sevdalis N, Vincent CA (2006) Measuring intra-operative interference from distraction and interruption observedin the operating theatre. Ergonomics 49:589–604. CrossRefGoogle Scholar
  14. 14.
    von S und Torney M, Dell-Kuster S, Hoffmann H, von Holzen U, Oertli D, Rosenthal R (2016) Microcomplications in laparoscopic cholecystectomy: impact on duration of surgery and costs. Surg Endosc 30:2512–2522. CrossRefGoogle Scholar
  15. 15.
    Antoniadis S, Passauer-Baierl S, Baschnegger H, Weigl M (2014) Identification and interference of intraoperative distractions and interruptions in operating rooms. J Surg Res 188:21–29. CrossRefGoogle Scholar
  16. 16.
    Zheng B, Martinec DV, Cassera MA, Swanström LL (2008) A quantitative study of disruption in the operating room during laparoscopic antireflux surgery. Surg Endosc 22:2171–2177. CrossRefGoogle Scholar
  17. 17.
    Gawande AA, Zinner MJ, Studdert DM, Brennan TA (2003) Analysis of errors reported by surgeons at three teaching hospitals. Surgery 133:614–621CrossRefGoogle Scholar
  18. 18.
    Weerakkody RA, Cheshire NJ, Riga C, Lear R, Hamady MS, Moorthy K, Darzi AW, Vincent C, Bicknell CD (2013) Surgical technology and operating-room safety failures: a systematic review of quantitative studies. BMJ Qual Saf 22:710–718CrossRefGoogle Scholar
  19. 19.
    Goldenberg MG, Jung J, Grantcharov TP (2017) Using data to enhance performance and improve quality and safety in surgery. JAMA Surg 152:972–973. CrossRefGoogle Scholar
  20. 20.
    Amoore JN (2014) A structured approach for investigating the causes of medical device adverse events. J Med Eng 2014:1–13. CrossRefGoogle Scholar
  21. 21.
    Health C for D and Event Problem R Codes—Device Problem Code Hierarchy. Accessed 2 Sept 2017
  22. 22.
    CFR—Code of Federal Regulations Title 21. Accessed 2 Sept 2017
  23. 23.
    Brown S (2004) Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration1, 2. J Am Coll Surg 199:374–381. CrossRefGoogle Scholar
  24. 24.
    Verdaasdonk EGG, Stassen LPS, van der Elst M, Karsten TM, Dankelman J (2007) Problems with technical equipment during laparoscopic surgery: an observational study. Surg Endosc 21:275–279. CrossRefGoogle Scholar
  25. 25.
    Courdier S, Garbin O, Hummel M, Thoma V, Ball E, Favre R, Wattiez A (2009) Equipment failure: causes and consequences in endoscopic gynecologic surgery. J Minim Invasive Gynecol 16:28–33. CrossRefGoogle Scholar
  26. 26.
    Riggs MK, Bohm MR, Mountain PJ (2016) Examining relationships between device complexity and failure modes of minimally invasive surgical staplers. In: ASME 2016 international mechanical engineering congress and exposition. American Society of Mechanical Engineers, Phoenix, pp V003T04A014–V003T04A014Google Scholar
  27. 27.
    Kwazneski D, Six C, Stahlfeld K (2013) The unacknowledged incidence of laparoscopic stapler malfunction. Surg Endosc 27:86–89. CrossRefGoogle Scholar
  28. 28.
    Paparella S (2005) Inadvertent attachment of a blood pressure device to a needleless IV “Y-site”: surprising, fatal connections. J Emerg Nurs 31:180–182. CrossRefGoogle Scholar
  29. 29.
    Albayati MA, Gohel MS, Patel SR, Riga CV, Cheshire NJW, Bicknell CD (2011) Identification of patient safety improvement targets in successful vascular and endovascular procedures: analysis of 251 hours of complex arterial surgery. Eur J Vasc Endovasc Surg 41:795–802. CrossRefGoogle Scholar
  30. 30.
    Wubben I, van Manen JG, van den Akker BJ, Vaartjes SR, van Harten WH (2010) Equipment-related incidents in the operating room: an analysis of occurrence, underlying causes and consequences for the clinical process. BMJ Qual Saf 19:e64–e64. CrossRefGoogle Scholar
  31. 31.
    Khan SA, Kumar A, Varshney MK, Trikha V, Yadav C (2008) accidentally falling instruments during orthopaedic surgery: time to wake up! ANZ J Surg 78:794–795. CrossRefGoogle Scholar
  32. 32.
    Pereira BMT, Pereira AMT, Correia CDS, Marttos AC Jr, Fiorelli RKA, Fraga GP (2011) InterrupÃ\SÃ\mues e distraÃ\SÃ\mues na sala de cirurgia do trauma: entendendo a ameaÃ\Sa do erro humano. Rev ColÃcopyrightgio Bras Cir 38:292–298CrossRefGoogle Scholar
  33. 33.
    Verdaasdonk EGG, Stassen LPS, Hoffmann WF, van der Elst M, Dankelman J (2008) Can a structured checklist prevent problems with laparoscopic equipment? Surg Endosc 22:2238–2243. CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of SurgeryUniversity of TorontoTorontoCanada
  2. 2.International Centre for Surgical Safety, Li Ka Shing Knowledge Institute, St. Michael’s HospitalTorontoCanada

Personalised recommendations