FDA said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.
Out of more than 55,000 operations completed with the affected instruments, “there has been one reported instance of interrupted motion resulting in an imprecise cut, along with two additional instances of perceived resistance,” the company said in the statement dated Nov. 19. “No patient complications were reported in association with these three instances.”
In October, the company sent an “urgent medical device correction” letter to users warning of potential problems with metal coating on a lamp that may not be compatible with the control board.
This--of course--affected the company's stock prices.