Davinci- what a scam

Bigger scam, our system or these people coming on our board trashing our business until they get a payout and then will never be heard from again? Tick tock tick tock.

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You are just like one of those commentators from Fox News only giving a portion of the sound bite. Here is the rest to provide context.

This complaint is being reported due to the following conclusion: the customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.

There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

“The site's system logs were reviewed with a procedure date of (b)(6) 2018, error 23075 was identified pointing to the right gimbal, indicating that it possibly moved without the surgeon's hands on the grip” idiot

Btw, what is up with the known issue of the wires breaking at the weld? What is your welding process in manufacturing and at which plant?

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new Adverse Events report robot "OUT OF CONTROL" AND "MOVING ON ITS OWN"

It was reported that during a da vinci-assisted surgical procedure, the instrument was "out of controll during procedure". It was identified that the wire of the double fenestrated grasper instrument was loose and broken"

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

You are just like one of those commentators from Fox News only giving a portion of the sound bite. Here is the rest to provide context.

This complaint is being reported due to the following conclusion: the customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.

There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

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new Adverse Events report robot "OUT OF CONTROL" AND "MOVING ON ITS OWN"

It was reported that during a da vinci-assisted surgical procedure, the instrument was "out of controll during procedure". It was identified that the wire of the double fenestrated grasper instrument was loose and broken"

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

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That movie and all these posts attacking the company have literally had no negative impact on Intuitive's business.

Take a look at the posts on this thread and you can see why. I get the sense there were a lot of lawyers chasing patients who had less than desirable surgical results with the da Vinci. A little expert tip for ya: start with your surgeon despite what your lawyers want you to believe. The da Vinci doesn't control itself, the surgeon controls it.

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The Bleeding Edge on Netflix will expose ISI.

That movie and all these posts attacking the company have literally had no negative impact on Intuitive's business.

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The District Court for the Northern District of California has helped victims of Intuitive Surgical's da Vinci robot get $42.5 million in damages! These awards are one of many and will open up the floodgates to other victims of ISI from around the world!

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This is a very sad and uniformed opinion. I hope patients do their research and not listen to something like this.

MAUDE - Manufacturer and User Facility Device Experience

279 records meeting your search criteria returned- Manufacturer: intuitive surgical Event Type: Death Report Date From: 01/01/2000 Report Date To: 04/13/2018

Manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Manufacturers must send reports of such deaths, serious injuries and malfunctions to the FDA. Importers must send reports of deaths and serious injuries to the FDA and the manufacturer, and reports of malfunctions to the manufacturer.

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Wrong about what? The only thing I can think these people were wrong about is their decision to have a surgery using a defective davinci robot. As too what happened to them, there is a trial scheduled in June and there are reports of settlements daily. Your support is not needed. However, as a human you be better hope you'r not a victim one day. Especially with a mouth like yours.

This is a very sad and uniformed opinion. I hope patients do their research and not listen to something like this.

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I want to root for a patient group but these guys make it so incredibly hard. From the DWAS name to the uneducated responses, there isn't much to root for. From the looks of it, these accusations have been going on for a couple of years but nothing has really happened. Maybe I was right to not root for them, because they're wrong.

Wrong about what? The only thing I can think these people were wrong about is their decision to have a surgery using a defective davinci robot. As too what happened to them, there is a trial scheduled in June and there are reports of settlements daily. Your support is not needed. However, as a human you be better hope you'r not a victim one day. Especially with a mouth like yours.

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You does not understand this cause this conspiracy is the FDA with Intuitive. They is killing patients cause they know about the bad defects and pretend it's not. Y'all will see in 2018 cause this is the year DWAS makes ISIS closed forever! Unplug the robot!

DWAS

I want to root for a patient group but these guys make it so incredibly hard. From the DWAS name to the uneducated responses, there isn't much to root for. From the looks of it, these accusations have been going on for a couple of years but nothing has really happened. Maybe I was right to not root for them, because they're wrong.

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If the FDA found evidence showing the da Vinci system was at significant risk they would have pulled it from the market in 2010 and 2011. It is 2018 and you're grasping for straws. The FDA is not looking for patients to get injured or killed by a device that they have approved. I'm sorry your family member was injured but these very well could have happened in a similar surgery where the da Vinci was not used and traditional instruments were instead.

You does not understand this cause this conspiracy is the FDA with Intuitive. They is killing patients cause they know about the bad defects and pretend it's not. Y'all will see in 2018 cause this is the year DWAS makes ISIS closed forever! Unplug the robot!

DWAS

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"The Food and Drug Administration says Intuitive Surgical, which makes the da Vinci surgical robot, broke procedures when it blamed customers about problems with the robot without first alerting regulators.

In what is known as a "483" letter following a recent inspection the FDA said that between January 2010 and December 2011 Intuitive received 134 complaints and filed 83 medical device reports related to "tip cover issues."

According to the FDA, in October 2011 Intuitive sent customers a letter with "suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments." However, Intuitive later recalled the defective insulation tips and micro crack prone, monopolar instruments.

The very same defective tools Intuitive Surgical blames surgeons for misuse, causing injuries and deaths.

The "correction," the FDA said, was in response to complaints regarding "arcing through damaged tip covers that caused patient injury."

An FDA 483 letter is a notice to a company that FDA inspectors have found a possible violation of federal regulations. The letters are not a final determination by the agency. The company can respond to and contest the findings of such letters." Blast from the past. Juries are going to love hearing this. OVER and OVER and OVER.

LOVE DWAS

If the FDA found evidence showing the da Vinci system was at significant risk they would have pulled it from the market in 2010 and 2011. It is 2018 and you're grasping for straws. The FDA is not looking for patients to get injured or killed by a device that they have approved. I'm sorry your family member was injured but these very well could have happened in a similar surgery where the da Vinci was not used and traditional instruments were instead.

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Your use of grammar makes even less sense.

Direct questions

The question mark is used at the end of a direct question. Indirect questions take a period.

Direct question: What is she doing tonight?

Indirect question: I wonder what she's doing tonight.

Direct question: The question is, Does anyone support this legislation?

Indirect question: The question was whether anyone would buy Intuitive Surgical bullshit at court.

Now trying again.

"The Food and Drug Administration says Intuitive Surgical, which makes the da Vinci surgical robot, broke procedures when it blamed customers about problems with the robot without first alerting regulators.

In what is known as a "483" letter following a recent inspection the FDA said that between January 2010 and December 2011 Intuitive received 134 complaints and filed 83 medical device reports related to "tip cover issues."

According to the FDA, in October 2011 Intuitive sent customers a letter with "suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments." However, Intuitive later recalled the defective insulation tips and micro crack prone, monopolar instruments.

The very same defective tools Intuitive Surgical blames surgeons for misuse, causing injuries and deaths.

The "correction," the FDA said, was in response to complaints regarding "arcing through damaged tip covers that caused patient injury."

An FDA 483 letter is a notice to a company that FDA inspectors have found a possible violation of federal regulations. The letters are not a final determination by the agency. The company can respond to and contest the findings of such letters." Blast from the past. Juries are going to love hearing this. OVER and OVER and OVER.

LOVE DWAS

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You're either stupid or not well informed. I am betting both are true. The fact is, courts have NOT bought into Intuitive surgical bullshit. Please read the following.

US District Judge Edward Davila said that plaintiffs in the case had sufficiently plead the case, claiming the company had inflated its stock prices with misleading statements and sales practices.

The court roundly rejected this argument. First, the Court noted that "given the entirety of the allegations, it defies reason that Intuitive's nine directors could be blind to widespread regulatory violations being committed with respect to the Company's sole product." As such, the court found that Plaintiffs had "shown that all nine directors faced a substantial likelihood of personal liability for failure of oversight." The court then found that under the allegations, "all nine directors faced a probable liability risk of personal liability for false and misleading statements" made in the company's SEC filings. Finally, the court found that the allegations showed that five of the company's nine directors, constituting a majority of the board, sold company stock "motivated by inside information" about the undisclosed safety defects and regulatory violations, exposing them to a "substantial personal liability risk for insider trading."

The court concluded that under these circumstances, "none of the nine directors . . . were sufficiently disinterested, independent, or conflict-free such that a fair and neutral decision would have been made on any pre-suit demand." Accordingly, the court denied the defendants' motion to dismiss and ordered them to answer Chicago Teachers' allegations within 20 days.

Click here to access a copy of the August 11, 2017 Notice of Hearing and Proposed Derivative Settlement.

Click here to access a copy of the August 9, 2017 Order Setting Settlement Hearing and Approving Notice of Proposed Derivative Settlement.

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