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

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.

Teleoperation in surgical robotics--network latency effects on surgical performance.

A teleoperated surgical robotic system allows surgical procedures to be conducted across long distances while utilizing wired and wireless communication with a wide spectrum of performance that may affect the outcome. An open architecture portable surgical robotic system (Raven) was developed for both open and minimally invasive surgery. The system has been the subject of an intensive telesurgical experimental protocol aimed at exploring the boundaries of the system and surgeon performance during a series of field experiments in extreme environments (desert and underwater) teleportation between US, Europe, and Japan as well as lab experiments under synthetic fixed time delay. One standard task (block transfer emulating tissue manipulation) of the Fundamentals of Laparoscopic Surgery (FLS) training kit was used for the experimental protocol. Network characterization indicated a typical time delay in the range of 16-172 ms in field experiments. The results of the lab experiments showed that the completion time of the task as well as the length of the tool tip trajectory significantly increased (alpha< 0.02) as time delay increased in the range of 0-0.5 sec increased. For teleoperation with a time delay of 0.25s and 0.5s the task completion time was lengthened by a factor of 1.45 and 2.04 with respect to no time delay, whereas the length of the tools' trajectory was increased by a factor of 1.28 and 1.53 with respect to no time delay. There were no statistical differences between experienced surgeons and non-surgeons in the number of errors (block drooping) as well as the completion time and the tool tip path length at different time delays.

Objective assessment of telesurgical robot systems: Telerobotic FLS.

The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Fundamentals of Laparoscopic Surgery (FLS) program contains curriculum that includes both a cognitive and psychomotor skills. In this research the use of FLS Block Transfer task is used to evaluate the performance of surgeons' teleoperating the University of Washington Surgical robot. The use of the FLS Trainer Box and accessories kit provides a well-defined series of tasks that can be repeated by any researchers working in the field of surgical robotics so that systems can be evaluated using a common method.

Telesurgery via Unmanned Aerial Vehicle (UAV) with a field deployable surgical robot.

Robotically assisted surgery stands to further revolutionize the medical field and provide patients with more effective healthcare. Most robotically assisted surgeries are teleoperated from the surgeon console to the patient where both ends of the system are located in the operating room. The challenge of surgical teleoperation across a long distance was already demonstrated through a wired communication network in 2001. New development has shifted towards deploying a surgical robot system in mobile settings and/or extreme environments such as the battlefield or natural disaster areas with surgeons operating wirelessly. As a collaborator in the HAPs/MRT (High Altitude Platform/Mobile Robotic Telesurgery) project, The University of Washington surgical robot was deployed in the desert of Simi Valley, CA for telesurgery experiments on an inanimate model via wireless communication through an Unmanned Aerial Vehicle (UAV). The surgical tasks were performed telerobotically with a maximum time delay between the surgeon's console (master) and the surgical robot (slave) of 20 ms for the robotic control signals and 200 ms for the video stream. This was our first experiment in the area of Mobile Robotic Telesurgery (MRT). The creation and initial testing of a deployable surgical robot system will facilitate growth in this area eventually leading to future systems saving human lives in disaster areas, on the battlefield or in other remote environments.