Robotic Arms Used to Perform Surgery may Seize Up and Stop Working Mid-operation, Manufacturers Warn

Intuitive Surgical, California, makes the $1.5million robotic surgery system
It has put out an 'urgent medical device recall' for the robotic arms of its da Vinci Surgical System that could affect 1,386 robotic arms in use globally
The device is used to treat cancer and has been credited with reducing the side-effects of surgery, but has also be linked to injuries and deaths


The arms of a robot widely used in keyhole surgery could stall and seize up while performing delicate operations, manufacturers have admitted.

Intuitive Surgical, which make the $1.5million robotic surgery system said friction in the arms of some devices might make them stall.

The company has put out an 'urgent medical device recall' for the robotic arms of its da Vinci Surgical System, which is used to treat cancer and has been credited with reducing the side-effects of surgery.

There have been reported problems with the system, including several disturbing incidents including a robotic hand that wouldn't let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.

These accidents - and even several deaths linked to the system - have led to investigation.

Now the company has voluntarily admitted that there could be a problem with some of the robotic arms used in its system.

The problem could affect 1,386 robotic arms in use across the world, according to the U.S. Food and Drug Administration (FDA), which has been investigating the safety of the robot.

A statement on its website said stalling in the robotic arms of the system could result in a sudden 'catch up' if a surgeon perseveres with a move, despite slight resistance from the machine.

It said: 'Reports of friction within certain instrument arms can interrupt smooth instrument motion.

'This can be felt by the surgeon as resistance in the movement of the master. In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.'

The system's manufacturer has faced questioning over the safety of the da Vinci system's arms as well as its training procedures, Bloomberg News reported.

Last month the FDA warned the number of system malfunctions, injuries and even deaths connected with the robotic device have doubled in 2013 compared with 2012.

Intuitive put out its own statement about the recall last month.

It said: 'Intuitive Surgical has issued a field notice informing affected da Vinci S, Si, and Si-e System customers that it is voluntarily initiating a correction for the Patient Side Manipulators on the Patient Side Cart and repairing or replacing them as needed.'

Talking about its safety record, the California-based company said: 'Out of more than 55,000 procedures completed with this group of instrument arms, there has been one reported instance of interrupted motion resulting in an imprecise cut, along with two additional instances of perceived resistance.

'No patient complications were reported in association with these three instances.'

The company said it is performing 'comprehensive' inspections to test its equipment in the field and repair or replace affected robotic arms.

It said that around 70 per cent of the inspections are complete and most of the robotic arms did not require any adjustments.

The da Vinci has four spider‑like arms, controlled by the surgeon, which hold cutting instruments to make tiny incisions and remove cancerous tissue part using images from a telescope to guide the surgeon.

It features a tiny telescope that is placed inside an incision in the patient's body.

The telescope takes images from two points, which are relayed back to a console so the surgeon has a 3D image on-screen while he operates.

Previous evidence has shown that using these robots mean significantly less blood loss, reduced risk of blood transfusion and probably a shorter overall recovery time.

For surgeons, who control the robot while sitting at a computer screen rather than standing over the patient, these operations can be less tiring - and robotic hands don't shake.

A 2002 study in the journal European Urology found prostate cancer surgery done by da Vinci robots had better outcomes for continence and cancer control than keyhole approaches done by the human hand.

The robot is also now used for heart bypass surgery, heart valve repair and hysterectomy.


Source: MailOnline



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