|Intuitive Surgical's da Vinci surgical system--Courtesy of Intuitive|
Problems and bad press involving Intuitive Surgical's ($ISRG) da Vinci surgical robots have hit regularly all year, but a new controversy ups the ante, and it all comes down to friction. Bloomberg reported that the California company has issued a recall affecting more than 1,300 robot arms around the world because they may be producing too much friction in some of the surgical systems. When that happens, the da Vinci can choke during surgery and briefly stop working before it catches up.
The FDA reported the issue on its website, noting that Intuitive sent out an "urgent medical device recall" to affected customers on Nov. 11. Consider that the da Vinci system costs about $1.5 million per unit, and that the recall affects 1,386 da Vinci system arms globally, and you get a sense of how serious the problem is.
Bloomberg contacted Intuitive about the issue, and the company directed it to a statement on the matter that it had quietly posted online on Nov. 19.
In its statement, Intuitive termed the recall a "voluntary product correction." The company acknowledged the issue affected da Vinci S, Si and Si-e System customers. Intuitive said it has taken steps to address problems with the systems' instrument arm (known formally as the da Vinci Patient Side Manipulator) and that its efforts to fix the matter will involve "repairing or replacing them as needed."
Intuitive said it notified regulators about the action and was quick to downplay the matter and emphasize the safety steps it has taken.
"Out of the 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," Intuitive said in its pre-Thanksgiving statement. "No patient complications were reported in association with these three instances. Intuitive Surgical is performing comprehensive inspections to test all affected instrument arms and repair or replace them as needed."
An Intuitive spokesperson emphasized to FierceMedicalDevices via email that the 1,386 number affects da Vinci device arms and not the systems themselves. What's more, the spokesperson said, Intuitive has completed 70% of the inspections relating to the recall "with the vast majority having no issues." Additionally, he said, "the company did the recall to make surgeons and customers aware of the potential issue and there isn't a concern with patient safety."
At minimum, however, the recall is yet another blemish for Intuitive in what has become a mixed year. Bloomberg noted, for example, that the company's third-quarter earnings declined due to lower revenue, and that it sent out an "urgent medical device correction" letter in October, warning of potential issues due to the metal coating on a lamp that potentially didn't work with the system's control board. The FDA has also handled a significantly higher number of adverse event reports relating to surgical robots made by Intuitive.
The FDA said in a recent report that the devices can still be beneficial to patients but that training is lacking. An FDA warning letter knocking the company for not sufficiently reporting patient "adverse events" and other issues earlier this fall also spooked investors. And studies from Johns Hopkins and elsewhere have noted that robotic surgery-related complications are grossly underreported.
Intuitive's stock is down from a high of about $400 in mid-October and has fluctuated wildly since then. It traded at $370.51 late on Dec. 4, down .62%.
- read Intuitive's statement
- here's the full Bloomberg story