Urgent safety warning regarding the da Vinci
"The company sent an “urgent medical device recall” Nov.
11 alerting customers of the issue, which affects 1,386 of the
systems worldwide, the 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.
More details of recent da Vinci complications can be read here and here.
You can also read this paper, systematically overviewing da Vinci errors.
You can also read this paper, systematically overviewing da Vinci errors.
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