Da Vinci Robotic Devices: ACOG Statement & FDA Warnings
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UPDATED: Dec 15, 2014
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Since 2013, the medical industry has increasingly come under scrutiny for their use of the da Vinci Robotic device in performing surgery.
The Da Vinci Robotic Device
Intuitive Surgical, Inc (ISI) is the manufacturer of the da Vinci robotic surgical system devices. ISI also provides maintenance for the devices and trains surgeons on how to use them. The da Vinci system is a robotic device used by surgeons to assist with surgical procedures. The device is computer-operated with remote controllers, similar to a gaming consol. A specially trained surgeon controls the device, and it allows them to perform invasive surgeries without their hands coming into contact with their patient’s body.
ISI Criticized for Aggressive Marketing of Da Vinci
In March of 2013, the American Congress of Obstetricians and Gynecologists issued a statement critical of the aggressive direct-to-consumer marketing of these robotic devices. The ACOG stated that such marketing is misleading and makes the consumer believe that the device is the only best option. ISI aggressively marketed it as a safer option for invasive procedures. An aggressive marketing campaign promoted information directly to patients that the da Vinci system is the best device to use for most surgeries. However, the American Congress of Obstetricians and Gynecologists warned that patients should be advised that the device is best used for unusual and complex clinical conditions requiring surgery, not for all surgery.
In July of 2013, ISI was issued with a warning letter from the FDA regarding the maintenance of their robotic device. This letter included a variety of incidences, some dating back to October of 2011, that showed ISI had not followed appropriate protocol when it came to the reporting of certain field actions to the FDA, actions that were the result of defective parts and/or a previous failure to specify that pediatric patients should not be subject to the da Vinci TORS. The FDA warned ISI that their actions were in breach of federal law and that they needed to meet government regulation and standards. ISI went on to recall Version SII of their da Vinci device in May of 2013.
How An Attorney Can Help
Have you, or someone you know, undergone a procedure using the da Vinci system and suffered adverse results? You should contact an attorney to discuss the potential for litigation and your chances of compensation.