UPDATED Dec. 5, 8:45 a.m. with comment from an Intuitive spokesman
Sunnyvale, Calif.-based Intuitive sent an "urgent medical device recall" notice to healthcare providers Nov. 11 detailing the problem, according to the FDA.
"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," according to a notice posted yesterday on the federal watchdog agency’s website.
Intuitive posted its own notice about the problem Nov. 19, saying it would repair or replace the affected parts as needed.
"The company is taking this action after becoming aware that excessive friction within certain instrument arms could interrupt smooth instrument motion, which is felt as resistance by the surgeon. If a surgeon pushes through the resistance, the instrument could stall momentarily and then suddenly catch-up to the correct position," according to the notice. "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."
A company spokesman told MassDevice.com via email that Intuitive has finished 70% of its inspections, “with the vast majority having no issues.”
The recall, affecting 1,386 of the da Vinci device arms, is the latest in series of setbacks for Intuitive, ranging from a dramatic spike in the number of adverse events reported to the FDA to an insurer’s accusation that the company concealed the number of legal claims filed against it.
ISRG shares are down 24.8% this year and were trading at $371.17 apiece as of about 4 p.m. today, down 0.4%.