FDA Conducts Survey on Surgical Robot

Patients-complain-of-side-effects-after-undergoing-surgery-from-Da-VinciThe Da Vinci surgical system is a robotic surgical system which is produced by an American manufacturer, Intuitive Surgical. It was considered to be the first robotic system to be used in American operating rooms after it was approved by the US Food and Drug Administration (FDA) for laparoscopic procedures on July 11, 2000, according to media reports. The surgeon performs the procedure several feet away from the operating table using the hand controls at the computer system. The three or four-armed robot is able to see inside a patient’s body using a tiny video camera attached to one of the arms. However, FDA is investigating a spike in reported problems involving Da Vinci surgical robots, which were used in nearly 400,000 surgeries across the United States in 2012.

FDA wants to better understand users’ perspectives on the different challenges raised when using the Da Vinci Surgical System interface for performing surgery versus using conventional surgical procedures. The letter indicated that agency officials would speak with surgeons for up to an hour as part of a survey. The warning letter depicts the two problems the FDA observed during an inspection performed during the second quarter, according to the Intuitive Surgical. Additional steps were asked by the FDA to resolve the concerns, according to the company. The survey is believed to help assess the agency with the current and future trends in the robotic surgery. The agency regards the results of the survey as qualitative in nature and not quantitative.

Intuitive also faces of a number of Da Vinci lawsuits lodged in recent months alleging that surgeons with insufficient training inadvertently cut tissue with errant electricity from the robot’s electronic cutting tool, causing major complications.

References:

  • healthleadersmedia.com/page-3/PHY-291524/FDA-Probes-Docs-Over-da-Vinci-Robot-Problems##
  • medscape.com/viewarticle/803339
  • online.wsj.com/article/SB10001424127887324662404578332712134965802.html
  • advisory.com/Daily-Briefing/2013/04/12/FDA-launches-investigation-into-da-Vinci-complaints
  • nydailynews.com/life-style/health/surgical-robot-scrutinized-fda-deaths-nightmares-article-1.1311447
  • businessweek.com/ap/2013-07-18/intuitive-surgical-slumps-after-fda-warning-letter
  • bloomberg.com/news/2013-02-28/intuitive-surgical-robots-probed-by-u-s-in-survey-of-surgeons.html
  • theverge.com/2013/4/9/4204546/da-vinci-surgical-robot-fda-investigation-cmu-johns-hopkins-research
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