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Print 12 comment(s) - last by Moishe.. on Nov 8 at 3:03 PM

Some of these problems have resulted in the injury or death of patients

A new study shows that some problems and even deaths caused by surgical robots were not accurately reported (or in some cases, not reported at all) to the U.S. Food and Drug Administration (FDA). 

According to PBS, the study looked at the da Vinci Robotic Surgical System specifically, which is made by Intuitive Surgical. It's designed to perform complex surgeries with a minimally invasive approach while being controlled by a surgeon from a console. Medical professionals say the system provides smaller incisions, shorter hospital stays and less pain post-operation.

The study searched through several data bases over about a 12-year period of use of the da Vinci Robotic Surgical System. The study found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries. 
 
However, they also found eight cases where reports were inaccurate, including five cases where no FDA report was filed at all.

This is a pretty big deal, considering hospitals are required to report the incident to the manufacturer if a device malfunctions in any way, and then the manufacturer reports it to the agency. From there, the FDA creates a report for its Manufacturer and User Facility Device Experience database. 


Da Vinci Robotic Surgical System

"The Journal for Healthcare Quality article gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the FDA," said Intuitive Surgical in a statement last month. "Intuitive Surgical can only report adverse events after it becomes aware of them. We take this requirement very seriously and make every effort to account for all reportable events--even those from several years prior."

One such case was a patient's injury and death in 2009, but the incident couldn't be found in the FDA's database for that year. The study's authors found a "very late" report matching the patient's case in 2010. The FDA received the report two weeks after The Wall Street Journal ran a story about it.

This has raised questions for the need of a better standardized system for reporting malfunctions and other problems regarding the surgical robots

It also raises another important question: if problems occur during robotic surgery, is the doctor, the hospital or the manufacturer responsible? According to PBS, this introduces the potential issue of product liability. 
 
Intuitive Surgical also called for the study's authors to conduct a study that compares the under reporting of traditional open and laparoscopic surgical issues with robotic-assisted surgery.

The use of robots for laparoscopic surgery, which uses smaller incisions than in traditional surgery, was approved by the FDA in 2000. From 2007 to 2011, the number of da Vinci systems installed was boosted by 75 percent in the U.S. (compared to about 800 to 1,400 prior).

Source: PBS



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very misleading
By Bubbacub on 11/6/2013 6:43:07 AM , Rating: 3
i'm a surgeon and i think that this type of deliberately misleading article drives frivolous litigation - and raises everyone's healthcare costs.

a patients death does not equal surgical error.

the two events are conflated in the article and this is very misleading.

the da vinci robot is overwhelmingly used to treat patients with some form of cancer.

its unfortunate, but undeniably true that some patients who have surgery for their cancer die earlier than if they had not - shit happens and someone or something is not automatically to blame.

that a small number of people with serious life threatening illnesses die isn't really that much of a surprise.

the robotic system is not autonomous in any way - it is basically a very fancy scalpel holder and forceps - all the control is from the surgeon.

errors or problems in robotic surgery come under the same oversight as ordinary surgery i.e. there is little to no story here.

this kind of thinking in our society, which appears to be fixated on allocating blame and going to court immediately thereafter is what pushes up health care costs to their current unaffordable levels.




RE: very misleading
By room200 on 11/6/2013 7:07:48 AM , Rating: 3
Maybe it's just me, but I don't want my surgery performed by a doctor who, when told of unreported deaths, and injuries, responds "sh!t happens".


RE: very misleading
By Bubbacub on 11/6/2013 7:36:53 AM , Rating: 1
want doesnt come into it.

shit can and does happen

you can duck your head into the sand but the reality is that surgeons are human beings.


RE: very misleading
By kingmotley on 11/6/2013 11:01:42 AM , Rating: 1
And I would counter that shit doesn't just happen.

Unexpected things happen because we don't (yet) have the capability to account for everything that can and does happen. Given enough information and the ability to use all the information, there should be no unexpected results, but we aren't there yet.

Doctors do the best they can with what information is available using the best methods available to them. In 400 years, doctors will look at what we do today as being as barbaric as our doctors look at what was done 400 years ago. Such is progress and human knowledge and advancement.


RE: very misleading
By milktea on 11/6/2013 4:33:24 PM , Rating: 2
Agree on the fact that doctors/surgeons are human too. But just don't drink before the surgery ;)


RE: very misleading
By Moishe on 11/8/2013 3:03:29 PM , Rating: 2
He's got a great point. sh1t does happen and Americans are way too quick to assign blame and then assign a dollar value to that blame.

Americans are generally anti-risk, they want to live in a safe bubble. But that only works well when applied to things we don't "need." We can avoid the risk associated with new by sticking with old because the old is usually good enough. No big deal. But something like surgery is necessary. It's risky, but without it, you'll die. Do you want to take the risk or not?

You might think surgeons don't care, but it's not that. It's accepting reality and understanding that there are simply some things that blame cannot be assigned for.

Sh1t just happens sometimes. Unfortunately, Americans will falsely assign blame and ruin someone's life over it because we've been taught that we are "owed" or that we can't have closure without it.


RE: very misleading
By kattanna on 11/6/2013 10:11:03 AM , Rating: 2
quote:
i think that this type of deliberately misleading article drives frivolous page clicks


there.. fixed it for you

;>)

sad.. but true


RE: very misleading
By sorry dog on 11/6/2013 2:43:00 PM , Rating: 2
just as it is very mis-leading to say malpractice suits are the root of the healthcare cost spiral. While I don't deny it's a factor, I'd dare say that doctors over ordering tests and procedures to pad physician invoices to insurance is a much bigger reason for cost growth. Personally, I tend to think that if a doctor makes a mistake that he should not have made, and that costs a person their life or a leg or something then blanket capped the damages at $200k is not fair.

With that said, I agree the way this article reads makes question whether the injuries or deaths were statistically likely to happen whether the robotic tool was used or not.


Need to compare with human error numbers too
By Flunk on 11/5/2013 3:34:10 PM , Rating: 5
245 sounds like a lot of errors, and clearly it's not acceptable. But if there are 2000 or of these things in use on a regular basis that's not a large percentage of overall operations. I wonder how it compares to the stats for human error in similar operations.

It seems like this is something that needs to be investigated further.




By DNAgent on 11/5/2013 5:33:01 PM , Rating: 2
It's the FDA. Anyone who deals with them on a regular basis can assure you--they're investigating.


Rhetorical question
By Florinator on 11/5/2013 6:30:50 PM , Rating: 2
In the case of a plane crash, who's responsible, the airline, the pilot or the manufacturer?

Well, it could be any of the above, a human error could be a pilot's fault, lack of proper aircraft maintenance could be the airline's fault and manufacturing defects or software bugs could be the manufacturer's fault.

Same with the medical devices, I don't think there is one clear answer to this question.




RE: Rhetorical question
By milktea on 11/6/2013 4:37:43 PM , Rating: 2
It's very simple. When in doubt, just report it. Not placing any blames; just reports of what happened. How difficult is that? Experts can later decide on the root cause of the issue.


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