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.
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Acknowledgments
The authors thank Seattle Children’s Hospital for providing access to expired da Vinci surgical instruments for study.
Disclosures
No competing financial interests existed at the time this research was completed and this paper written. Since that time, however, Diana Friedman has accepted a position at Intuitive Surgical in an unrelated part of the company.
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Friedman, D.C.W., Lendvay, T.S. & Hannaford, B. Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study. Surg Endosc 27, 1503–1508 (2013). https://doi.org/10.1007/s00464-012-2659-8
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DOI: https://doi.org/10.1007/s00464-012-2659-8