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

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

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Funding

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

Author information

Authors and Affiliations

  1. Department of Surgery, University of Toronto, Toronto, Canada

    James J. Jung, Arash Kashfi & Teodor Grantcharov

  2. International Centre for Surgical Safety, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Canada

    James J. Jung, Sahil Sharma & Teodor Grantcharov

Authors
  1. James J. Jung
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  2. Arash Kashfi
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  3. Sahil Sharma
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  4. Teodor Grantcharov
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Corresponding author

Correspondence to James J. Jung.

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Disclosures

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.

Appendix

Appendix

See Table 6.

Table 6 Definitions of device-related interruptions and stapler-specific device failure subcategories
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Jung, J.J., Kashfi, A., Sharma, S. et al. Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies. Surg Endosc 33, 717–723 (2019). https://doi.org/10.1007/s00464-018-6254-5

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  • DOI: https://doi.org/10.1007/s00464-018-6254-5

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