Class II Recall for Stalling Surgical Robot

The company that aims to deliver the most precise of surgical procedures by virtue of its robotically controlled surgical arms, has warned its customers about the risk of occasional “stalling”, that may itself introduce the possibility of inaccurate cuts.

Background

Intuitive Surgery has enjoyed considerable success with its robotic daVinci system, a pioneering concept that has gained adoption across numerous specialties and for several procedures. We’ve followed the technology quite closely, including its birthing pains, which have included questioning of reported clinical results, alleged training deficiencies, FDA inspection woes and legal claims. Now, to add to the list, the company has written to its customers to notify them of problems reported with its Patient Side Manipulator, a component that is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. It seems certain instrument arms can suffer frictional resistance, with the potential to interrupt smooth instrument motion. This can apparently be felt by the surgeon as resistance in the movement of the master and can cause the instrument to stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.

Intuitive has written to customers worldwide, and in the US the FDA has issued a Class II recall notice which contains the instruction that users should contact the company to arrange an inspection visit and repair or replace components as necessary. That notice can be found here.

Company comments

“Out of more than 55,000 procedures completed with this group of instrument arms, there has been 1 reported instance of interrupted motion resulting in an imprecise cut, along with 2 additional instances of perceived resistance. No patient complications were reported in association with these 3 instances.”

Source: FDA

 

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