FDA Issues Class II Recall on Intuitive Surgical’s da Vinci Surgical Robot

The U.S. Food and Drug Administration (FDA) issued a Class II recall of Intuitive Surgical’s da Vinci surgical robots due to inadequate testing of thirty units.

Class II recalls indicate “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the federal watchdog agency.

According to the FDA, Intuitive Surgical sent Urgent Device Correction notices to all affected customers on June 27th regarding the fact that 30 da Vinci surgical robots may not have been properly tested. On July 11th, the FDA issued a class II recall statement on its website, noting that the affected parts are the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.  The FDA added that factory testing on those four components “may not be in compliance with UL standards” because one of the testing devices was malfunctioning.

On March 14th the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement warning consumers not to let aggressive marketing overshadow the risks of robot-assisted surgery. According to the news release, there is no proven evidence that results from the da Vinci surgical robot are as good as the cheaper, less invasive alternative methods, such as laparoscopic methods. ACOG, which represents approximately 56,000 physicians, is not the only organization expressing concerns regarding the safety and efficacy of robot-assisted surgery.

The Massachusetts Board of Registration in Medicine has highlighted the potential for serious complications in an advisory in March.  It stated that in light of growing reports of injuries associated with the da Vinci, there needs to be more oversight for surgeons and that patient should be warned about the risks. The Board cited several examples of patients who had serious bleeding, adhesions and perforation or damage to their bowel and ureter. In one case, a piece of rectal tissue was left inside a patient’s abdomen.

The manufacturer also failed to adequately examine the long-term results and appears to have minimized or withheld information regarding the actual extent of complications and injuries following da Vinci surgical procedures.

As we reported earlier, physicians receive only minimal training in the use of the da Vinci Surgical Robot. This, coupled with problems with the design of the robots, as well as inadequate testing of the units, has lead to serious injuries.

If you or a loved one has experienced problems as the result of a da Vinci surgical procedure, you may be entitled to financial compensation. Feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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