Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study

Friedman, Diana DW and Lendvay, T. and Hannaford, B. (2012) Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study. Surgical Endoscopy, 27. pp. 1503-1508.

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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 identi- fied 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.

Item Type: Article
Subjects: C Surgical Robots > C Surgical Robots(General)
Depositing User: Danying Hu
Date Deposited: 07 Jul 2015 21:28
Last Modified: 07 Jul 2015 21:28
URI: http://brl.ee.washington.edu/eprints/id/eprint/95

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