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Intuitive Surgical, Inc. Message Board

  • captzorro_2000 captzorro_2000 Apr 12, 2014 7:36 AM Flag

    ISRQ failed to adequately disclose and/or misrepresented the potential risks and/or benefits of the da Vinci Surgical System.

    The FDA previously had linked Intuitive ISRG da Vinci Surgical System to injury and death, that was in 2004.

    There were 4,798 adverse events reported in the U.S., including 85 deaths, 414 patient injuries and 3,402 device malfunctions (As reported by Seeking Alpha).

    A death and injury rate of 50 reports per 100,000 procedures in 2012.

    And there were the concerns about doctor training.

    ISRQ as of 12/2013:

    About 76 individual product liability lawsuits filed in various state and federal courts.

    In addition, ISRQ has been named as a defendant in a purported class action now in the Federal courts .

    The cases raise a variety of allegations purported defects in the da Vinci Surgical System and/or failure on our part to provide adequate training resources to the healthcare professionals who performed plaintiffs’ surgeries.

    The cases further allege that ISRQ failed to adequately disclose and/or misrepresented the potential risks and/or benefits of the da Vinci Surgical System.

    The Plaintiffs’ attorneys continue to engage in well-funded national advertising campaigns soliciting clients who have undergone da Vinci surgery and claim to have suffered an injury.

    ISRQ continues to receive claims as a result of these advertising efforts…

    info from varies source including, 2013 10Q.

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    • That sounds about right. 4798/1,500,000 procedures in that time... Equals about 0.3% adverse events rate for things such as ureteral injury, cuff dehiscence, etc. It's about 0.5% in laparoscopy.
      Thanks for pointing out how safe these robotically assisted procedures are.
      You're a champ!

      • 2 Replies to ntlslp
      • One death is a tragedy over hundreds of deaths is a travesty ! This with robotic technology that is suppose to reduce complications by 99%. our bodies were not designed to be treated like a a "Detroit assembly line" where robotic arms fix the problem in droves. The technology is flawed until proven other wise!

      • ntlslp@hotmail.com ntlslp Apr 12, 2014 5:42 PM Flag

        If you are going to steal my name, please do not use words like "champ". Yes, unreported injuries and cases migrated to open surgery at the first hint of complications lead to a low reported complication rate for the Davinci. The real issue is the lack of benefit as it relates to the additional cost. No way hospitals bleeding from their current machines are going to buy another one. You need twice as many procedures for the current installed base to break even financially. No room for the new machines.

 
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