Robotic Surgery Complications Going Underreported 99
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."
Re:It's normal (Score:2, Informative)
But don't worry, automated cars will work better.
The robots aren't automated. They're controlled by a surgeon using a control panel in the room next door.
Re:iRobot (Score:4, Informative)
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.
Re: IT IS CALLED BUSINESS !! (Score:5, Informative)
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:I wish I could say this stage was unnecessary (Score:4, Informative)
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 [wikipedia.org] 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
Re:It's normal (Score:4, Informative)
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.