Johnson & Johnson drops the Ethicon 4000 stapler with Ethicon 3D staple technology: Ready for Ottava
- Steve Bell
- Jun 11
- 12 min read
Updated: Aug 30
When a company updates its class leading product line - such as with surgical stapling - It is of course big news. Because it is an important multi billion dollar product for them... and a critical part of the portfolio for minimal access surgery. But maybe also important it is a core profit contributor.
But when companies drop new products they leave interesting clues around and sometimes they raise more questions than apparent answers. The Ethicon 4000 stapler is one of those giant breadcrumbs. Very very interesting
Now you put into that the statement that this technology will be integrated into OTTAVA in the future and well - you now really have my attention.
I have covered over and over again in many articles about robot stapling the “dos and do nots” and it will creep up again in this article as I noticed something… and well… hmmmm
So let’s get straight into it…
What’s in a name?
Before anything else I had to do a quick double check. You see previous versions of the endo cutters were named the Ethicon Echelon 3000 etc. Note the brand architecture - Ethicon key brand - Echelon sub brand and the number.
What grabbed my eye was a very different but important branding. This product is the main brand Johnson & Johnson, Sub brand Ethicon 4000. It is not the Ethicon Echelon.
I’m weird - so if you give me an Itch I go scratch it I’m afraid…
First strange thing. There is a version of this stapler actually called the Echelon 4000 - and that got 510K (FDA) way back at the end of October 2024.
But oddly (and I mean very odd) - in such a vicious stapling war - the company decided not to launch it. Why?
Well hang on. Instead of launching they decided a rebrand to the Ethicon 4000 and resubmitted the stapler for another 510K. Which was cleared 14th May 2025.
That is a big effort and a risk to go through. It means they were willing to give up almost 6 months of sales for a simple “name change”???
I have scoured all the documents of this stapler and cannot see any difference between the two 510Ks except for the name change. Even the product codes are the same so I am, concluding it is just a brand name difference.
Everything on the two submissions remains the same - even (weirdly) some Ethicon naming spill over on the Echelon submission in the actual paperwork. But hey.
So was this just a weird blip? Did it go in mid brand change? Or did someone just transcribe Echelon on to the documentation because they didn’t get the memo? Whatever it is ... it's strange.
This is important - because it signifies (in my mind) an important brand architecture change which has been creeping across Johnson & Johnson Medical devices. Where JNJ is the dominant brand not Ethicon. Same seems to be creeping in across other divisions. But that brand correctness is so important they were willing to give up 6 months of market time to get it right. So it is important for me at least.
What’s changed in the stapler?
The press release talks about two key things when it discusses the 4000. It talks about the “end effector” hmmmmm that is absolute robotic speak and not an accident. Instead of talking about the jaws of the stapler. Take that as a very big signal. Ethicon instruments (the brand they will mount onto Ottava) will be the same “End effectors”.
Ottava will have the tried and tested - trusted Ethicon “End effectors” - watch for more of this. Smart move and right move. And that is why you need the brand restructure.
It would be odd to have the Ottava with Ethicon instruments bringing Echelon end effectors. Except for the energy where it is the Harmonic end effectors - or the Enseal end effectors. You see the issue with the current brand architecture. It has too many layers.
A critical marketing spin of Ottava is “The exclusivity of Ethicon instruments” on Ottava. You want an Ethicon stapler on a robot - you need Ottava. Period.
But to make that "period" work you need a brand architecture of ETHICON as the main instrument sub brand. So look now for a succession of rebranding to Johnson & Johnson master brand and Ethicon sub brand - and the slow elimination of older sub brands. This is a critical part of the exclusivity theme on Ottava.
Back to the end effector.
One of the most crucial things in a surgical robotic stapler is the “stability and security” when the robot smoothly fires the stapler. It looks to me from the renders they have worked on the hinge mechanism - maybe some anvil thickness changes - the drive mechanism. Knowing robots - they want maximal jaw opening - but when closed the tip of the jaws are as accurate and controlled as the heel of the jaws. So I think they’ve worked that out.
This is a guess - BUT it feels like they have purposefully changed the cartridge design - why?
One of the biggest challenges of trying to do open - lap and robotic stapling is that the same cartridges work across the variants. So today if Ottava could take on the Echelon 3000 cartridges - you would need to validate each and every variant of cartridge - and that is a huge amount of money and time.
Instead if you have a limited 60mm range out for the Ethicon 4000 with a unique cartridge (and now only 4 - talk later on this) your validation on the robot at first stapler launch is just 4X cartridges. And that is important for speed to market and early clearances. If they did this for this reason - smart. You do not want to be in validation hell.
Side point:
Clearences. Now the Ottava team are already behind Medtronic and Intuitive in the robot race. Getting the de Novo FDA clearance on a robotic system is hard enough. Would they dare to try and get the stapling technology on at launch? That would be a brave team to try that. Instead the sensible route is get the robot with minimal functionality through de Novo. Then use your own system as predicate to 510K additions in such as staplers - which already have 510K as well.
It’s the sensible way to go. But I’ve seen weirder executive decisions for sure.
The angle of dangle
I have written extensively here on this blog that you better not put a laparoscopic end effector on a robot. The big stapling companies have only ever needed YAW (side to side articulation) on a manual stapler. And many have forgotten why it works in manual. I know why it works in manual - but not in robotic. But I’m not giving that secret away today.
Something very subtle changes when you mount a stapler on a robot. And you need Pitch as well (up and down.)
Just remember that one of the single most important reasons people buy and use robots is “Endo wristed” technology. Articulation on a robot SUCKS! Ask Senhance. Ask Avatera… the list goes on.
The standard - in fact the gold standard today is Sureform by Intuitive. And that standard is a wristed stapler. Pitch / Yaw / Rotation. You can get that jaw (end effector) into any position and angle you need…. “ON A ROBOT!”
If they port this yaw only to the robot. Man will that be a risk of users feeling a nixed system. And I do not care how many labs they’ve done with close KOLs - real world users out there that are not the “robot experts” as KOLs will reject it. Once you’ve had a full wristed stapler - on a robot - the rest feels - well feels poor. There's no going back.
Plus if you look at a Sureform move - it is fluid - smooth like any wristed instrument. Fast - accurate. If this simple yaw gets ported onto Ottava as is - with the motor “flex” and it is as slow as the manual. Again it will not meet the expectations of the market. Fluid - responsive movements are the gold standard.
Here's a nice example:
Now I apologise to all the JNJ Ottava engineers if I have this wrong and you have a wristed - fluid version of this for Ottava. I can only go off what I see here on the Ethicon 4000 launch.
Brand new 3D stapling technology
Well not really new and not all 3D. But a step in the right direction against DST.
So 3D “bent” stapling has been on the Ethicon circular stapler for some time. It is a great innovation where the staples form in a 3D shape. That improves tissue pressure spread - and allows longer leg lengths to be formed into a wide range of staple closure heights.
In the circular when combined with (GST) Gripping Surface Technology (bumps) they demonstrate excellent leak rates. Impressive - but a 2 row stapler. Hmmmm,.
So the 3D technology is not new - even if sort of feeling new for many.
But on an endo cutter you don’t have 2 rows of staples - you have 3 on either side of the knife blade. And that creates a few problems for engineers.
First you need to remember that these staplers need to get down 12mm or 10mm and now with some Sureform - 8mm ports. So diameter of the shaft and “end effector” width get smaller. And real estate gets less.
It is a miracle that engineers can get all that gubbins (technical term) into the shaft and more so into the business end - end effector (robot speak) where they can drive 6 rows of staples and a knife. It is super impressive - just go take one apart. I have. I’m weird.
So when you have six rows of staples either side of a knife you have very limited real estate. In a 2D staple format the staples and driver and anvil slots (where the staple forms against the metal opposite the cartridge) are linear. Now to get that gorgeous 3D staple shape all of that is offset and non linear so takes up more lateral space.
And well if you wanted all 6 rows to be 3D - then the cartridge should have to probably get wider. If it gets wider the whole thing might get past 12mm. The Echelon 3000 is 12mm so I imagine the 4000 is 12mm (TBC).
So we are at the upper limit of cartridge width - so there is no more real estate… so…
The two outer rows on each side of the blade are 3D (rows 1 & 2 and 5 & 6) - where as the engineers maybe ran out of room so the two rows directly next to the blade slot are 2D.
So the 4 rows in 3D and the 2 rows in 2D clearly works. And work well I guess - but just to be 100% straight it’s a mixture of 3D and 2D to get the effect they want.
BUT what that does is get you? Besides tissue effect directly - and better spreading of loads - thinner thicker variances. In combination with GST and the 3D / 2D blend - it means that across each cartridge they can get a wider tissue variance - and that means more overlap between cartridges - to the point where the “Gold” middle for diddle” sized cartridge is no longer needed.
So now you have just a white (vascular) - Little boy Blue - Jolly Green giant - and Black extra thick / long cartridge selection. 1 less cartridge
That does a few things:
For the company 1 less validation set of cartridges (great for Ottava) - plus simplified manufacturing
For the surgeon - simplified sizing choices and probably more margin of error for them
For the hospital - less shelf space and SKUs so less cost
So even if not all 3D across the staple cartridge - it does allow for better performance and gets the desired effect they needed so who really cares.
Why that matters for Ottava
In my humble opinion - It matters in many ways for Ottava.
Firstly it potentially does help in very subtle ways for the economics - by having less stock on shelves you reduce costs. And every little helps. Even if it is just tying up capital.
But is also makes it a little easier for the users - less "having to guess" or rather judge the tissue thickness and select the right cartrridge. So if you don’t get it quite 100% right - be it blue or green - you are most likely going to get a good result even with a bit of over tissue compression or under compression. Good for lap but also for robotics.
It will also (or should) allow that 60mm to be used along more tissue length with more variance - as that 3D technology will help if part is too thick and part is too thin. Like in bariatrics.
And as absolutely everything for the Ottava launch points to bariatric being the first robotic procedure they get FDA on - it makes utter sense to have a 60mm that can absorb varying tissue thicknesses and potentially even eliminate the need for buttress material (more cost savings). This is their trial they are doing now - bariatrics. So all of this is pointing to get a decent bariatric tool kit based around Ottava.
Hot on the heels will most likely be Colorectal and then Thoracic for Ottava. It’s their big stapling markets, and I feel this robot is all about staplers and energy from ETHICON - Exclusive - only on Ottava. I mean they did stick it all over the landing page for the Ethicon 4000. And marketeers often give a lot of tells away in the order of imaging. Yes this is Ethicon 4000 but it speaks to procedure focus and that will run into Ottava (I'm guessing.)
So I’ll correct myself a little - if the focus is bariatrics then the lack of “pitch” on the stapler is less crucial as the angles you need to get to on bariatrics is less aggressive than some other procedures like deep pelvis or apex of lung. But that could be a false sense of security. If it works in bariatrics it may not spill across to other areas. Let's see.
Note: I personally think bariatrics is an odd first choice by the way. A 2023 report showed only 15.3% of bariatrics was done robotic assisted. And add to that that over 30% are done in ASCs where robots are not as common and well…
Plus who could have guessed the GLP1 impact? No one.
But on the upside they could get an “umbrella procedure” which will also give wider Upper GI procedures (fortegut). Plus if the stapler is only yaw capable - it will be less impacted in these procedures (hypothetically.) Plus they do have a very loyal customer base in this segment that have not all gone across to robotics so far, so are not ingrained Intuitive users (Why not? Why not????)
Now one potential downside of the 3D stapling is the greater width needed in the cartridge housing - and if they ran out of room for the last two rows (only my speculation) then I think they will really struggle to ever get that down from a 12mm to an 8mm. And well.. that will be important in the next 3 years - why?
Port hopping - with the ability to use the stapler through any robotic port on any robotic arm is a big advantage. And it is a massive need in thoracic surgery between the ribs. IF and it is a big IF Ottava comes out with a 12mm stapler and cannot get that down to 8mm - that is a big challenge as Sureform already has 8mm staplers. And 8mm will become the norm soon.
The inability to port hop could also amplify the missing pitch degree of freedom (if that is also true).
Sorry I can only go off what I see. If they can get to 8mm then well done to the engineers.
Summary
Very nice bump in the stapling line for Ethicon / JNJ. Some nice additions with the redesigned stapler and the 3D cartridge technology. It keeps the brand moving forwards - keeps them relevant and sets them up to stick it on Ottava. It allows a decent bariatric focused hand held should they go Ottava de Novo no stapling route first.
Let's not forget the realities of hand vs robotic stapling here > https://www.howtostartupinmedtech.com/post/robotic-stapling-vs-manual-stapling-the-results-might-surprise-you
It also allows them to keep the noise up and constant about Ottava. Which is critical for them as they continue with their clinical studies. It will be some time until FDA clerance and they need to stay "relevant." This and Dualto all helps - if you can halo on the word Ottava. Keeping it front of mind.
It is not accidental that Dualto - with Ottava compatibility
Ethicon 4000 - with Ottava compatibility
Ottava is being touted a lot (right move) and the overall branding is being subtly shifted. It says they are all in on Ottava - and if the trial in bariatrics was not going well - they would NOT be touting this stapler at the bariatrics meeting whilst talking Ottava futures.
So that indicated to me the bariatric trial is going well, and they continue towards the submission of the Ottava system with FDA as they announced.
For me that is actually one of the biggest reads in their announcement. And the fact again Erik Wilson was quoted - just gives me more and more warm n fuzzy that they are progressing with that trail. Wishing them continued success with Ottava and a good (limited) launch of the Ethicon 4000.
These are simply speculations by the author based on publicly available snippets. It contains some wild speculation for educational purposes only
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