As Intuitive Surgical Faces Scrutiny Over Alleged Da Vinci Robot Surgery Complications, Company Receives FDA Warning Letter Seeking Additional Steps to Resolve Issues Cited During Recent Inspection.
The Da Vinci robot surgery complication lawyers at Wright & Schulte LLC are disturbed by a recent report from Bloomberg.com that detailed a U.S. Food & Drug Administration (FDA) warning letter received earlier this month by Intuitive Surgical Inc., the manufacturer of the Da Vinci Surgical System. The FDA letter, dated July 17th, asks Intuitive to take additional steps to resolve two issues the agency observed during a recent inspection of the company’s headquarters. According to the FDA, that inspection revealed that Intuitive Surgical did not adequately report Da Vinci Robot System corrections and patient adverse events.
- Tears and/or burns of the intestines
- Punctured blood vessels
- Punctured and/or cut ureters
- Severe bowel injuries
- Vaginal cuff dehiscence
- Excessive bleeding
- Surgical burns
According to a recent NBC News report, the Da Vinci Surgical System was used in 400,000 operations last year, including hysterectomies, prostate surgeries and heart surgeries. Advocates for robotic surgery claim that such procedures result in minimal bleeding, fewer and smaller scars and faster recovery times. However, according to the Bloomberg.com report, a review of FDA adverse event reports shows injuries involving the Da Vinci robot surgery procedures doubled in the first six months of 2013 compared with a year earlier. The FDA is now surveying doctors to determine if the spike in da Vinci surgery complication reports could indicate that there is a problem with the technology.
According to Bloomberg.com, the FDA warning letter followed the agency’s issuance of a 483 inspection report on May 30th. Among other things, that report cited Intuitive Surgical for failing to inform the FDA of a customer warning it issued in October 2011 regarding a problem that had been associated with reports of da Vinci surgery complications.
In a recent filing with the U.S. Securities and Exchange Commission (SEC), Intuitive Surgical disclosed that it had been named in 26 Da Vinci surgical robot lawsuits that allege a variety of serious injuries, including surgical burns, organ and tissue damage, and torn blood vessels. According to court documents, patients in those lawsuits say they suffered a number of serious da Vinci surgery complications, including surgical burns, organ and tissue damage, and torn blood vessels, in procedures with the robot.
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