ENDOWRIST STAPLER SYSTEM: 510(k) K113706

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Anonymous

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Any details? Does anyone knows anythinh about this? I got this from FDA website.


Device Classification Name system,surgical,computer controlled instrument20
510(K) Number K113706
Models 410298,272300,272032, 41645W,41645B,41445G
Device Name ENDOWRIST STAPLER SYSTEM
Applicant INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale, CA 94086

Contact meghna sridharan
Regulation Number 876.150021
Classification Product Code NAY22

Date Received 12/16/2011
Decision Date 10/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
 












Anonymous said:
Any details? Does anyone knows anythinh about this? I got this from FDA website.


Device Classification Name system,surgical,computer controlled instrument20
510(K) Number K113706
Models 410298,272300,272032, 41645W,41645B,41445G
Device Name ENDOWRIST STAPLER SYSTEM
Applicant INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale, CA 94086

Contact meghna sridharan
Regulation Number 876.150021
Classification Product Code NAY22

Date Received 12/16/2011
Decision Date 10/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Click to expand...

Hello general surgery! We are on baby!
 






Ka-boom.

I am going to take pleasure in guttin Cov and Eth. Absolutely genius that the stapler uses the same generator as the vessel sealer. This is going to be fun.
 




































the cov arrogance is over...so superior arent you...where is the powered stapler n. haven? scratching your head? we...they...I...but....not....if....
3 months...suppliers.....POM.....purchasing.....marketing......
testing....management....quality....and.....soon.....
1 year......changes....uh....tried...can't.....no.....yes.....tomorrow......plan.....duh.

Black & Decker here we come
 






Does anyone know if the stapler is based on Cardica's IP, or Power Medical (since acquired by Covidien)?

Cardica was touting their stapler as "staple on a strip". ISI was working with Power Medical first, but Cardica's IP sounded more appealing.

Just curious.
 
























cant wait to see what they have docs using it for - "hi doc, i would really like to talk about our value proposition of using the new stapler to perform any toe clipping procedure you may have on your schedule - irealize that it will cost 3 times as much but i am sure you will pee down your leg when you sit in the console - great value doc...wouldnt you agree??"
 






Anonymous said:
cant wait to see what they have docs using it for - "hi doc, i would really like to talk about our value proposition of using the new stapler to perform any toe clipping procedure you may have on your schedule - irealize that it will cost 3 times as much but i am sure you will pee down your leg when you sit in the console - great value doc...wouldnt you agree??"
Click to expand...

Dude, not sure what planet you live on, but here on earth "value" does not figure into the equation with robotic surgery. If history is any indicator, hospitals will buy the stapler and surgeons will use it, without any significant clinical evidence of superiority and despite the increase in cost. Get used to it.
 






Anonymous said:
Dude, not sure what planet you live on, but here on earth "value" does not figure into the equation with robotic surgery. If history is any indicator, hospitals will buy the stapler and surgeons will use it, without any significant clinical evidence of superiority and despite the increase in cost. Get used to it.
Click to expand...

True story from large hospital in PA.

When doc requested early access to this stapler technology in value analysis committee, or director reply was "Sorry, but only Dr. Evil gets to have lasers mounted to the heads of his sharks."

Though I find great humor in this response, it also shows the trivial reputation ISI is fostering with their gagdets & their sales strategy. The docs have no power anymore. Value committees hold the pursue strings. And last I checked, these guys make their bonus' on reducing OR costs, not increasing them.
 






Anonymous said:
True story from large hospital in PA.

When doc requested early access to this stapler technology in value analysis committee, or director reply was "Sorry, but only Dr. Evil gets to have lasers mounted to the heads of his sharks."

Though I find great humor in this response, it also shows the trivial reputation ISI is fostering with their gagdets & their sales strategy. The docs have no power anymore. Value committees hold the pursue strings. And last I checked, these guys make their bonus' on reducing OR costs, not increasing them.
Click to expand...

Value analysis committees?! Never in my 4 years at ISI, have I even had to hear the words 'value analysis committee'. I've never been in the purchasing office of a hospital since taking this job. Docs request to C-suite, and C-suite gets it done. Administration doesn't usually like us, b/c we have so much power being a monopoly and we can instill a stronger sense of urgency. If the right docs want our new technology, they usually don't have to wait too long to get it.
 






Anonymous said:
Value analysis committees?! Never in my 4 years at ISI, have I even had to hear the words 'value analysis committee'. I've never been in the purchasing office of a hospital since taking this job. Docs request to C-suite, and C-suite gets it done. Administration doesn't usually like us, b/c we have so much power being a monopoly and we can instill a stronger sense of urgency. If the right docs want our new technology, they usually don't have to wait too long to get it.
Click to expand...

Dude, if you are truly that ignorant to think you have this much power after 4 years in your role, then you really have no idea how hospitals work.

http://www.iienet.org/uploadedfiles/Webcasts/SHS_VA_Presentation.pdf
 






Anonymous said:
Dude, not sure what planet you live on, but here on earth "value" does not figure into the equation with robotic surgery. If history is any indicator, hospitals will buy the stapler and surgeons will use it, without any significant clinical evidence of superiority and despite the increase in cost. Get used to it.
Click to expand...

Hey "dude" - dont you have a role play to do today???get on it and make sure your business plan is tight...and what is our core message??? and get your ass on that conference call because your ass will be fired in 18months....here is your quota for the month...yea and its 30% over last months but fck you...deal with it....now start role playing NOW BOY!! DUDE and make sure you clip my nasty toenail ....
 






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