FDA warning letter to robotic surgery manufacturer, which complains of “negative press”

Bloomberg News reports:

“Intuitive Surgical Inc. (ISRG), the maker of robotic surgical devices, fell in extended trading after it disclosed a Food and Drug Administration warning letter and reduced its sales forecast.

The company received the warning letter July 17, Chief Executive Officer Gary Guthart said during a conference call with analysts to discuss quarterly earnings. FDA inspections in April and May found a number of deficiencies, including that the Sunnyvale, California-based company in some cases hadn’t adequately reported device corrections and patient adverse events, according to a report dated May 30.

Safety and cost effectiveness of the company’s da Vinci robot devices have been under scrutiny. Bloomberg News reported in February that U.S. regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009.

Guthart said the agency is asking for additional steps to resolve two of the observations in the inspection report.

“We believe these issues are addressable and will continue to work with the FDA to ensure this is resolved to their satisfaction,” Angela Wonson, a company spokeswoman, said in an e-mail after the call.

Intuitive’s robotic surgery system, used in more than 1,300 hospitals, is the company’s primary product and has been the subject of negligence lawsuits alleging that patients were injured during surgeries with the device. Cancer surgery, hysterectomies and gall bladder removals are among the procedures conducted with the robot, which costs about $1.5 million each.”

Reuters reported:

“Intuitive Surgical, which until the first quarter had been accustomed for several years to ever-surging demand for its robots and procedures, said business was also being hurt by “negative press.” That was a reference to recent media reports questioning the cost effectiveness of the costly robotic procedures.”

As documented on this site, the company has profited from years of breathless, gee-whiz news coverage.  If you’re going to play the manipulate-the-media-for-marketing game, you may stand to gain something, but you may stand to lose something.  Tradeoffs.  Just like with the use of the technology itself.  Some of the chickens may be coming home to roost.


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Comments (3)

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Sharon Roper

July 27, 2013 at 12:53 pm

What a wonderful article!!! I had an ovary removed by the Da Vinci Robot and have not been out of bed in two and one half years. Cut was a vaginal cuff, that led to bleeding for a month, an intestine, and my bowel. My physician is a gynecological oncologist, but I did not have cancer and I had already been told that. Just that I had a lot of a lot of adhesions and I would be safer in her hands. But I was not in her very capable hands, a robot was doing the surgery and I have her surgical notes and she is quite honest, she says in her notes, “I oversewed the intestine , which was the proper thing to do when you have cut something.” Now, a vaginal cuff is something a gynecologist makes for a woman who has her uterus out. Mine was removed in the seventies and held up until the robot cut it. I could have died. But, instead I have constant debilitating pain, in spite of drugs and shots in my back and into my vagina. Ouch!!! Sorry to be explicit, you may edit if I should not use that word. I go to doctors two to three times a week, but that is so hard when you have trouble sitting. I signed an informed consent, so I can do nothing about this concerning my surgeon and I would not anyway. She is a nice woman who is a victim also. I feel differently about Intuitive. And have called a few lawyers, but made no decision yet.
I have been pestered by everyone of wanting my case. But one wanted me to sign a paper that his firm
could take out bank loans in my name to pay specialist and travel expenses. I also am allergic to most medications and my doctors would do anything for me. But, I have been hospitalized four times for plain medicines, like baclofen and Benadryl. I have good insurance, but some people do not, and I count my blessings. Everything I have said can be verified. I am calling FDA Monday. I needed to see this article. Please understand if you have robotic surgery, my surgery forty years ago was better and I healed, my surgeon was a human. We can get too smart for our own good, technologically speaking.

Sharon Roper