Robotic Surgery Complications Going Underreported

First time accepted submitter neapolitan writes "PBS has a report on the difficulties of tracking the complications arising from surgical robotic systems, particularly the Da Vinci robotic surgery apparatus. The original study (paywall) notes that there is a large lag in filing reports, and some are not reported at all. It is difficult to assess the continued outcomes and safety without accurate reporting data."

Comments

It's normal

[nospam007]

Those robotic surgeons operate 24 hours a day 7 days a week, they don't have time to write reports.

Re:It's normal

[Eggplant62]

Bullshit. I make quite a good living from transcribing operative notes for these very surgeries. From the reports I see, they do make mistakes, but not as many as one would think one would while using robotic equipment.

Re: IT IS CALLED BUSINESS !!

[Anonymous Coward]

Its called lawsuits, that's why the are not reporting it. Slashdot should post the same article over how many human surgeries that end in complications go unreported those types of surgeries are by far would exceed the lack of proper reporting on robotic complications, which is a huge huge problem of the "health care system/medical industry".

Let's not try and minimize the complications from just surgeries. We're told half-truths with damn near every drug we try too. We all know that within a group of 100 people trying a new drug, there will be some percentage of that group where death is an acceptable side effect.

Then again, when they're (semi) truthful about a new drug, and spend the last 27 seconds of a commercial rattling off the side effect list, doubt I'm going to be any less worried about taking the new drug, wondering how many billions in profits they're trying to protect just long enough to avoid the major lawsuits and change the drug name.

Re: IT IS CALLED BUSINESS !!

[Neil Boekend]

Its a risk not to report it. If things are working as they should a manufacturer who does NOT report a problem and gets caught should loose his license to produce any medical grade works. For a single fault.
There are lives at stake. The least they should do is give info for accurate statistics.

It's even worse than that!

[tlambert]

It's even worse than that!

All the primary sources which would let us know about this are behind paywalls, so even when you post them on slashdot, nobody can read the freaking things, so it doesn't matter...

I wish I could say this stage was unnecessary

[The_Laughing_God]

When I was in medical school (decades ago), we had a lecture by one of the pioneers of endoscopic gall bladder surgery (cut some 1-2cm slits and use long-handled tools and a tiny camera to cut/remove/etc) which I well knew was already preferable to the "open procedure" that slashed the patient open (classic surgical proverb: you can never have too much exposure) so you could have the working space to reach in and do it with your big mitts)

I was a big fan, but as a student of both philosophy and the history of science I had to ask how he justified performing the procedure *before* (until) he got the complication down to the level of the standard open incision. He was outraged (as were my classmates) and tersely stated that he had gotten consent (not knowing that I'd done a thesis on the inadequacies and inherent ludicracy of getting "informed consent", especially based on information from the surgeon who wishes to do the procedure).

It was a sincere question, one that I felt could not answer to my own satisfaction (his answer didn't help; he'd simply been looking to "the medical advance" and had never been trained in genuine ethics), but despite that, I feel that he had done the right thing, and that tens of millions have greatly benefited since.

Though not all would-be 'medical advances' end so salubriously, the sad fact is, we don't know any better way -- and I'd wager that we'll have workable fusion generators long before we have a better usable method for making medical advances. "First, do no harm" was a simplistic principle suited to the era before Christ when a doctor was as/more likely to do harm as/than good. (Note that the Hippocratic Oath forbids surgery outright)

We are now skilled enough that some of our advances seem "too good to deny to all comers" without full data -- but where are we to get that data, except by trial (and error). We are not yet advanced enough that MOST of our attempts at medical advance are so beneficial, nor are we advanced enough to have a much better alternative to "try it and see".

Re:I wish I could say this stage was unnecessary

[quantumghost]

When I was in medical school (decades ago), we had a lecture by one of the pioneers of endoscopic gall bladder surgery (cut some 1-2cm slits and use long-handled tools and a tiny camera to cut/remove/etc) which I well knew was already preferable to the "open procedure" that slashed the patient open (classic surgical proverb: you can never have too much exposure) so you could have the working space to reach in and do it with your big mitts)

I was a big fan, but as a student of both philosophy and the history of science I had to ask how he justified performing the procedure *before* (until) he got the complication down to the level of the standard open incision. He was outraged (as were my classmates) and tersely stated that he had gotten consent (not knowing that I'd done a thesis on the inadequacies and inherent ludicracy[sic] of getting "informed consent", especially based on information from the surgeon who wishes to do the procedure).

It was a sincere question, one that I felt could not answer to my own satisfaction (his answer didn't help; he'd simply been looking to "the medical advance" and had never been trained in genuine ethics), but despite that, I feel that he had done the right thing, and that tens of millions have greatly benefited since.

I think you answered your own question right there. The benefits of the procedure outweighed the risks. Informed consent, even for risky surgery, is still valid....so long as you properly inform the patient of the risks and benefits of the procedure. The patient gets to make their own decision. I consent patients for emergent (crash) procedures on a frequent basis. They are so sick that they may not survive the operation; however, without one they will certainly die. Most choose to take the risk. (Some decide that enough is enough and wish to be made comfortable, which is a valid option)

Now you can always argue that the patient, not being a physician, will never truly understand the risks, but that's the imperfect world we live in. OTOH, if this physician did not go through all of the risks, then that's another story.

Though not all would-be 'medical advances' end so salubriously, the sad fact is, we don't know any better way -- and I'd wager that we'll have workable fusion generators long before we have a better usable method for making medical advances. "First, do no harm" was a simplistic principle suited to the era before Christ when a doctor was as/more likely to do harm as/than good. (Note that the Hippocratic Oath forbids surgery outright)

We are now skilled enough that some of our advances seem "too good to deny to all comers" without full data -- but where are we to get that data, except by trial (and error). We are not yet advanced enough that MOST of our attempts at medical advance are so beneficial, nor are we advanced enough to have a much better alternative to "try it and see".

Now here's the rub....is robotic surgery any better, or offer benefit above, laparoscopic surgery? I will say with a decent amount of authority, there are very few procedures that have any advantage done robotically (namely those deep in the pelvis) - but note, they can still be done laparoscopicallyor even open. But there are very inherent risks....the robot removes all haptics from the surgeons hands (versus being mildly reduced in laparoscopic procedures). The first exercise you ever do with a robot is rip a piece of suture apart....you never get to feel how much tension is on it - so you "learn" what the limits look like, as opposed to feel like. There are other things inherent to the robot that also make it more difficult such as clutching (think of how you lift your mouse to move it back to the center of the mouse pad when you try to scroll a long distance) and the lack of knowledge of where your instruments are pointing.

To a lot of surgeons out there, robotic surgery is a solution looking for a prob

Da Vinci was great for me, maybe not for others

[madro]

I needed mitral valve repair surgery, and I was a good candidate for robotic surgery: relatively young, good health (other than the valve), not obese (fat gets in the way). Instead of sawing my sternum and spreading my chest open, the surgeon (who has a lot of experience in both robotic and open heart surgery) was able to go in through my right side and leave a 3-inch scar and three puncture wounds. I was in the hospital Tuesday morning, and out Friday afternoon. I'm grateful to have had access to this technology. The benefits of robotic surgery compared to open heart surgery are clear (at least in my case).

But when a hospital has a large fixed cost to acquire technology, it is all too tempting to spread that cost out over a greater number of surgeries. The benefits are not nearly so clear in surgeries that don't require bone-breaking or bone-sawing. If someday I need gall bladder surgery, or if my spouse needs a hysterectomy, I would have a strong preference to avoid robotic surgery unless a skilled surgeon can make a compelling argument that the specifics of our case are a good fit for robotic assistance. (And believe me, I read as much of the medical literature as I could in making the decision: when one of the surgical steps is, basically, "shut down the heart," you want to know as much as you can. Open heart surgery for valve repair is a well-understood, well-practiced technique, but for me the decision to use the robot was about the reduced shock to the body, shorter recovery time, and reduced scarring.)

Surprise?

[fuzzyfuzzyfungus]

Has anybody here ever had users who were willing to file and capable of filing proper bug reports or trouble tickets?

Re:iRobot

[ebno-10db]

I called this back in July

Your comment was very speculative. Much hospital equipment has malware, so it must be a problem for da Vinci? Or maybe da Vinci's have better computer security. I don't know, but your comment is very speculative.

The lawsuits for the Da Vinci Robot have been going on in my area for at least a year or more.

Intuitive Surgical is a great target for lawsuits because they have deep pockets. Maybe there were one or two was legitimate suits that were won, and now everyone else is piling on, regardless of the merit of their suits. Or maybe they're all valid lawsuits. I don't know - but neither do you.

What about the training surgeons?

[ebno-10db]

What kind of training do surgeons undergo for using the da Vinci? That could be a big factor.

Da Vinci aside, what kind of training do surgeons undergo for regular laproscopic surgery? I would think/hope that people coming out of their residencies learned it from the get go, but what about surgeons who've been practicing for 10 or 20 years? I understand that regular laproscopic can be tough, if for no other reasons than that the tools operate backwards, and visibility can be an issue (those are some of the things the da Vinci is supposed to fix). Wish I could find the link, but it was reported that laproscopic worked better than traditional open, but only if the surgeon had good training and lots of experience.

Re:Way the world works, baby

[Samantha Wright]

There are eight known cases of under or non-reporting as evidenced by PACER and LexisNexis, i.e. cases that led to legal complaints. The number could be a little bit larger, although probably not by much.

I find it interesting that the Da Vinci name is still on the market; it carries a lot of negative connotations from early tests where it was used in fully-automated knee and hip surgery (although I think the current robot is different from the infamous one.) It tended to cause a great deal more damage than it fixed, as while it was perfectly good at fixing bone, there was no consideration whatsoever for soft tissue and, IIRC, it just cut its way in. It sounds like something out of Terminator when you hear it described in detail.

Re: IT IS CALLED BUSINESS !!

[Anonymous Coward]

I write these reports and analyze medical device complaints for a living. There is a legal responsibility to report any death or serious injury involving a medical device to the FDA within 30 days (5 days for very serious malfunctions) of the Become Aware date. That's the date that the reporter became aware there was an incident. This is filed on an Medical Device Report (Form 3500A). Both the users and manufacturers are responsible for reporting with the manufacturer having an obligation to investigate each reportable event and file an investigative conclusion (Follow up) if the investigation is not completed on the first report. The FDA audits medical device manufacturers on a regular basis (yearly, bi-annually, or for cause) and any missed reports found in the manufacturers records are automatic observations (483). A failure to respond to the observations can result in a Warning Letter. Further failure to respond leads to the Justice dept. getting involved and potential device seizure, manufacturing stoppage, and corporate shut down actions (Consent decree). An individual caught hiding info or being untruthful can face permanent black listing from ever working in a medical or medical device manufacturing profession for the rest of their life.

Re:IT IS CALLED BUSINESS !!

[whitroth]

Are you a troll, or just that stupid?

You *certainly* don't want to live in any kind of society. People who sell things that break, badly, and don't admit it, can, if someone gets hurt enough, wind up in jail for fraud and criminal negligence.

And you... you're probably a libertarian, meaning you have the ethics and morals of a spoiled two-year-old.

                mark