Intuitive notified customers Nov. 15 of the potential for a component in the da Vinci’s Endowrist instrument to detach, saying the problem only affects devices made before October 2011 and that most of the affected products are not in use. The problem involves the jaw insert in Intuitive’s large needle drivers and mega needle drivers and "is typically apparent during standard visual inspection or use of the instrument," according to a press release.
"In most cases, a surgeon would immediately notice if detachment occurred during surgery," Intuitive said in a Nov. 19 statement. "The reported occurrence rate of jaw insert detachment is 0.01% per procedure."
Dave Rosa, Intuitive’s senior vice president of scientific affairs, told MassDevice.com today that the company estimates about 1,000 products were affected. The problem involved the brazing between the Endowrists’ tungsten carbide needle driver jaws and the instrument itself, he explained. Intuitive fielded 102 complaints out of roughly 1 million procedures likely to have been performed with the affected devices, Rosa said.
"Twenty-eight of those were procedural, and 1 of those was the 1 event that required a reoperation, a 2nd operation to remove it," he told us. "We’re on the way to getting confirmation and our products back from our customers."
The FDA said Dec. 16 that the pullbacks are Class II recalls, denoting "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the watchdog agency’s website.
Intuitive warned surgeons last month of another problem with the da Vinci device, issuing an "urgent medical device recall" Nov. 11 on the possibility that the instrument arm could "stall" during procedures. A company spokesman told MassDevice.com at the time that Intuitive had finished 70% of its inspections, "with the vast majority having no issues," as of Dec. 5.
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 closed up 1.5% at $361.24 apiece today.