According to reports, The Food and Drug Administration (FDA) has sent a warning letter to Intuitive Surgical, Inc., the makers of the da Vinci surgical robot, notifying the company that it violated federal procedures by circumventing the requirement of notifying the FDA prior to notifying its customers regarding problems with its product.
The FDA’s “483” letter, which has not yet been published on the agency’s website, reportedly states that during an almost two year period, the company received some 134 complaints and 83 medical device reports related to “tip cover issues” with the product.
Following these complaints, the company then allegedly sent its consumers a letter with suggestions and recommendations regarding the usage of its equipment. The letter was reportedly in response to complaints regarding arcing that was occurring in the case of damaged tip covers, which resulted in patient injury. Arcing occurs when electrical currents transfer inside of someone during the course of a surgery, somewhat like an electrical shock. The company failed to notify FDA prior to sending out the communication to its customers.
The incidence of these types of arcing incidents could raise questions regarding the safety of da Vinci systems, and the potential liability of Intuitive for the resulting personal injury that its product may cause. Some patients say that they suffered serious injuries because of the da Vinci robot.
For example, MSN News recently reported how at least one woman allegedly suffered a terrifying injury after undergoing robotic surgery for a hysterectomy. Five weeks following the operation, the woman reported feeling something “pop” when she went to the bathroom, and looked down to see her small bowel spill out. She reportedly filed a lawsuit in December of 2012.
Another lawsuit against the company claims that when a man’s 24 year old daughter underwent surgery for a hysterectomy for cancer in 2010, the robot reportedly burned her artery and intestines, resulting in her death two weeks later. There have allegedly been other reported incidents of burns and perforated intestines in patients who underwent robotic surgeries.
Manufacturers are required to exercise a certain level of care when designing, manufacturing, and inspecting its products prior to use by the consumer. Manufacturers must also warn the consumer of any dangerous conditions associated with the product. The failure to warn may serve as justification for a claim by a plaintiff injured by a dangerous product.
If you or a loved one has suffered injury or death as a result of a defective consumer product, you should contact an experienced products liability attorney as soon as possible in order to discuss your claim. You may be entitled to damages for your medical bills, pain & suffering, lost wages, or other claims. The hardworking personal injury attorneys at Lebowitz & Mzhen have many years of experience in zealously representing individuals in the Washington, DC area who have suffered injuries due to defective or dangerous products. Call us today in order to schedule a free and confidential consultation. You can contact us by calling (800) 654-1949 or through our website.
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