FDA launches investigation into da Vinci complaints
"The Food and Drug Administration is looking into a spike in reported problems during robotic surgeries. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.
Reports filed since early last year include at least five deaths. Whether there truly are more problems recently is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems.
A search for the company’s name in an FDA medical device database of reported problems brings up 500 events since Jan. 1, 2012. Many of those came from Intuitive Surgical. The reports include incidents that happened several years ago and some are duplicates. There’s also no proof any of the problems were caused by the robot, and many didn’t injure patients. They include:
- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.
- A Chicago man who died in 2007 after spleen surgery.
- A New York man whose colon was allegedly perforated during prostate surgery.
- A robotic arm that wouldn’t let go of tissue grasped during colorectal surgery on Jan. 14. “We had to do a total system shutdown to get the grasper to open its jaws,” said the report filed by the hospital. The report said the patient was not injured.
- A robotic arm hit a patient in the face during a hysterectomy. Intuitive Surgical filed the report and said it’s not known if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.
Complications can occur with any type of surgery, and so far it’s unclear if they are more common in robotic operations. That’s part of what the FDA is trying to find out.
Doctors aren’t required to report such things; device makers and hospitals are. It could also reflect wider use. Last year there were 367,000 robot surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif."
In the mean while, Seeking Alpha remains confident in the strength of the technology and the company:
"We certainly have yet to see any ill-effects from Citron's bearish research report on Intuitive Surgical's sales, which advanced 23% in the most recent quarter. We also don't see the FDA inquiry leading to much additional negativity, especially since it's the FDA's job to regulate the safety of medical devices. Possible FDA intervention is a risk, but not a large one, in our view.
At this time, we remain confident in holding shares of Intuitive Surgical in the portfolio of our Best Ideas Newsletter, but we'll be monitoring the situation to see if new system sales growth decelerates meaningfully. We think pushback against the efficacy of da Vinci machines is unlikely, but it could be a devastating headwind if it does surface, hence why the name commands just a small position of our portfolio."
We will keep you up-to-date, yet you can always check ISRG for instantaneous sentiments on the market.