Urgent safety warning regarding the da Vinci

"The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the FDA said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.

Out of more than 55,000 operations completed with the affected instruments, “there has been one reported instance of interrupted motion resulting in an imprecise cut, along with two additional instances of perceived resistance,” the company said in the statement dated Nov. 19. “No patient complications were reported in association with these three instances.”

In October, the company sent an “urgent medical device correction” letter to users warning of potential problems with metal coating on a lamp that may not be compatible with the control board. 

This--of course--affected the company's stock prices.

More details of recent da Vinci complications can be read here and here.

Source: Bloomberg, WSJ.
Image credit: EYMG -- of course, it is just a random other issue illustrated here 

Auris robot for opthalmic procedures

 New opthalmic dual-arm robot on the horizon (most probably a new generation of their parallel robot prototype): Dr. Fine and Nabil Simaan, head of Advanced Robotics and Mechanism Applications in the department of MecE at Columbia are co-founders of Auris Surgical Robotics. The president of the VC-funded company (est. investment is 1M) is Christopher J. P. Velis, the CEO is Fred Moll, who started at Intuitive, then launched Hansen, then Restoration robotics, and lately Auris (in 2011), besides other companies.

The robot has a total of 16 DoF, with a modular 2-DoF robotic tool for intraocular manipulation using inter-changeable surgical instruments. Dr. Fine and colleagues recently tested a prototype in animal models of retinal vasculature, successfully demonstrating cannulation of retinal veins followed by stent deployment. “To my knowledge, these are the smallest stents deployed in blood vessels,

Although the prototype exhibits 4.5 ± 0.9 μm translational precision, other features are undergoing further development or testing."

The product is planned to feature BIOLASE's patented WaterLase YSGGall-tissue atraumatic cutting technology.

Source: AAO,

Image credit: Inventorspot, NYT

Flickstop

Another surgical robot that has seen a lot of press is the IBIS system, a pneumatically powered device that works through “keyhole” sized incisions in a patient. This system, now in version 6, being developed as an open source design, and is potentially one-tenth the cost of devices like da Vinci. Kenji Kawashima, professor at the Tokyo University of Technology’s Institute of Biomaterials and Bioengineering, said that pneumatics was an easy choice for IBIS.

FDA releases final report on da Vinci

"The U.S. Food and Drug Administration (FDA) has issued a Final Report of findings gathered through a survey of surgeons throughout the United States who have used the da Vinci Surgical Robot in various medical procedures. The survey was conducted by the FDA, “to better understand [surgeon] perspectives on the different challenges raised when using the system interface to perform surgery versus using conventional surgical procedures.”

In receiving survey responses from eleven da Vinci robot surgeons, most from hospitals with a bed size of 100 or more, the FDA Report highlighted the following suggestions:

1. All survey respondents reported a need to perform multiple surgeries before feeling fully proficient in using the da Vinci surgical system;
2. That additional dry lab testing be offered and/or provided;
3. That pre-surgery training consist of a mandated threshold of hours.

While the FDA’s investigation into design problems continues, the FDA’s Report suggests that inconsistent surgeon training, or lack thereof, may be another problem in causing patient injuries. Jeff Berkley, chief executive of Mimic Technologies Inc., which makes robotic surgery simulators for training purposes, told Bloomberg, “[t]raining for robotics has been the wild, wild west for a long time,” and that hospitals and doctors realize, “they have to get their act together and start focusing on training.”
 Read more at PR Web.

CIS news

• Image-Guided Autonomous Robot (IGAR) for breast cancer detection
• Raven in Ender Games extra video coverage
• More development projects on the robot at UCSC
• A nice overview of the European surgical robotics projects  
• CTVNews coverage on CyberKnife

• ACMIT and Uni Zürich's Virtobot project is featured again on MedGadget
• Titan Medical began Tissue testing for its SPORT system 
• The SPORT system is foreseen to be launched at $600K price
• Case Western builds MR-guided catheters with the help of an NIH grant
• Training program lanuched for Corindus users 
• 10 Medical robots that could change healthcare
• Interesting medical robot patents
• Information Week staff pick for next gen robots
• Mimic Technologies releases MSim 2.2 update
• The debate over the price/value of the da Vinci is not settling: patients argue pro and con.
• More dispute over the meaning of FDA's MAUDE data regarding da Vinci complications
• Some sites discuss in a more balanced format the issue
• Robot Surgical Incidents May Pressure Hospital Training

• New robotics stock index introduced at NASDAQ, including the major surgical robotics companies (Intuitive, MAKO and Accuray)
• Learn more about GE's view on the future of helathcare
• Rent an RP-VITA for 5000/month!

Image credit: ARAKNES, CyberKnife, RP-VITA

Video Wednesday

A classic from Hopkins (featuring our good friend, Carol Reiley). Operation with a da Vinci became quite popular since then.

Robin Heart from Poland

Robin Heart, Europe’s first cardiac surgery robot with semi-automatic movements, an advanced human-machine interface, and a 3D virtual training system is now preparing for CE marking. The robot has an RCM structure, fully articulated wrists and a projected 3D display for the master interface (called Robin Heart Shell). Actually, there is a family of robots:

• Early prototypes: Robin Heart 0, Robin Heart 1, Robin Heart 2
• Clinical prototypes: Robin Heart Vision, Shell, Junior
• Current version: Robin Heart MC2, Shell2
• New development: Robin Heart Uni

"A 13-year-old project at the Foundation of Cardiac Surgery Development in Zabrze, Poland has built medical robots for carrying cardiac surgery with semi-automatic movements and a 3D virtual training system. The original robot and mechatronic tools have successfully completed the required laboratory tests and animal studies. Ensuring that all the vital electrical components of the robot system function properly and safely during the various stages of product development is a critical part of the research project.
Testing has to be undertaken in accordance with IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The components also have to be regularly inspected and tested to make sure they comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices. The team use a 288 automatic safety analyser supplied by Rigel, to test patient, enclosure and earth leakage as well earth continuity and insulation resistance."

On 17 May 2010 experiment on two pigs was carried out by Robin Heart mc2 type in Experimental Center of Medicine, Medical University of Silesia in Katowice. Elements of the operations performed on heart-related coronary artery. Robot itself was presented to the public shortly after completing the necessary work of protecting the intellectual property of the solution. 

There are numerous publications available on the system for more information. 

 
Source: RobinHeart, Electronics Weekly,