Monday, March 18, 2013

FDA ALARMED BY DA VINCI INCIDENTS, SURVEYS HOSPITALS


The Da Vinci surgical system has been under a barrage of pressure from all sides. On one end, a long list of adverse event reports are racked over it, followed by a burgeoning line of lawsuits against its manufacturer. Recently, the FDA is making rounds, sponsoring a survey to measure surgeon training and other complications related to the device in key medical centers and hospitals nationwide. Many conclude the future is bleak for this particular surgical care technology, Bloomberg reports.

A published March 1, 2013 article stipulates that the FDA is reaching out to various surgeons in top U.S. hospitals. The agency is gathering data from these health professionals on a list of criteria regarding Intuitive Surgical, Inc., maker of the Da Vinci surgical system.

The Da Vinci Surgical System Matters Looked Into

Although costing roughly $1.5 million each, the Da Vinci surgical system has been used in over 500,000 surgical procedures in 2012 alone. However, lawsuits against its manufacturer over the device have been climbing steadily.

Given the number of operations, doctors were then surveyed on what particular type of surgery they think the Da Vinci best and least fits. Also, the query wanted to know what kind of training these doctors have undergone to use the device.

Da Vinci Adverse Events Report Reach Alarming Numbers

Approved in 2000, the Da Vinci surgical system has been utilized to aid in gynecologic, urologic and laparoscopic surgery. The surgical robot has also been used to perform thyroid cancer procedures, gastric bypass surgery and gall bladder removal.

News of the survey was announced after Da Vinci adverse event reports swelled. In its report last January, hedge fund Citron Research detailed that roughly 4,600 reports of adverse events have been made because of the Da Vinci. FDA’s MAUDE database reveals that 3,900 of these reports were forwarded between the period of 2007 and 2012.

Da Vinci Lawsuits Claimed Serious Adverse Effects

Patients who have decided to file a Da Vinci surgical system lawsuit have done so because of the following adverse effects:

- excessive bleeding
- bowel Injuries
- cut ureters
- surgical tears/burns to arteries(other blood vessels)
- surgical tears/burns to vital organs
- death

The FDA is trying to get to the bottom of the matter. It wants to know if the long list of adverse reports is caused by the Da Vinci device itself or if there are other issues involved, according to an FDA spokeswoman, Bloomberg.com reported.

Considering Proper Compensation for Da Vinci Injuries

Getting injuries right from the surgical table is no joke. It is for this reason that seeking due compensation through a Da Vinci surgical system lawsuit could be a viable option.  An experienced personal injury lawyer should be able look into the merits of one’s case. Also, trusted sites, e.g.   www.rotlaw.com of RLG (Rottenstein Law Group), can give a free online legal review that could jumpstart one’s lawsuit over Da Vinci surgical system in no time at all.


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