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Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan. The system was first introduced as a prototype more than five years ago, but only received approval from the U.S. Food and Drug Administration (FDA) last year.

The first da Vinci Intuitive surgical robot was introduced more than a decade ago. When the company first went public, 15 years ago, it posted $10 million in annual sales, though the robot had only been used on 600 patients worldwide. The machine was thought by the medical professional community to be a great symbol of technological surgical advance, and, according to ModernHealthcare.com, “one of the most coveted status symbols of 21st-century medicine.” Yet the $2.3 million machine caused serious side effects and even injury in several patients, due to a disregard for patient safety on the part of the manufacturer and aggressive marketing tactics that often preceded patient testing.

As of 2013, according to ModernHealthcare.com, da Vinci was facing 25 product liability lawsuits. Many of the lawsuits allege that the manufacturer failed to properly train surgeons on how to use the innovative machine, and instead pushed through patents and marketing efforts before hospitals were equipped enough to handle the new technology.


With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition. There are several types of biopsies, according to WebMD. A surgical biopsy is one of the most common, and one of the most dangerous. In a surgical biopsy, a surgeon will either remove a part of tissue or a whole lump of tissue.

Because of the sensitive nature of biopsies, especially in cases in which a patient may already be ill or injured, equipment used in the procedure must be painstakingly considered. When biopsy medical devices are recalled, it can be a very serious issue for any patient involved. One such recall issued in 2011 just recently expired, but not before implicating thousands of patients. In 2011, DeRoyal Industries, based in Tennessee, issued a recall of their Geomed Biopsy Tray, an all-inclusive tool kit used by surgeons to perform the invasive procedure. According to the U.S. Food and Drug Administration, there were several products included in the tray that were potentially contaminated, including triad lubricating jelly, alcohol prep pads, and alcohol swabs.

According to the Committee to Reduce Infection Deaths (RID), Center for Disease Control data suggests that 1.7 million people contract infections in U.S. hospitals every year. The RID posits that number is actually seven times higher than that. Contamination from faulty medical equipment, such as the recalled biopsy tray, is one major culprit of such infection. Medical equipment that is not sterilized properly can not only transmit infection borne at the manufacturing site, but also obtained at the hospital itself.


The latest concern to rip though the field of medical devices is regarding the security placed within those devices. Recent pranks have demonstrated that it's extremely easy to hack into these devices and alter the controls, presenting a safety risk to the patients depending on these defective medical devices. The Center For Internet Security is a nonprofit group that provides advice to government agencies and private companies, and the group has announced the development of guidelines for medical device manufacturers to consider in the development and refinement of their products.

The goal of the report is to help manufacturers reduce malfunctions coming from computer viruses and to protect the confidentiality and integrity of the data connected to these devices. With some simple protection tips, individuals using critical machines can feel safer about the devices they use every day. The organization has requested information and cooperation from hospitals and medical professionals around the country in the development of these guidelines.

Defective medical devices present serious challenges to physicians who endorse them and encourage their use as well as the patients who rely on them. While some medical devices, like metal hip implants, have made the news as a result of faulty product design, security should be considered just as important a component as the development of safely operating machines. Someone using a medical device that can easily be hacked and tampered with presents a sudden and uncertain danger- the patient may not even realize what's happened to the device until it's too late. Without the protection of internet security and other protocols, thousands of patients are exposed to the potential risk of hacking and computer viruses. If you or someone you know has been a victim of a defective medical device, contact a qualified Illinois personal injury attorney with experience in defective medical devices.


The U.S. Food and Drug Administration (FDA) controls what drugs may be sold or prescribed to the public. If a prescription drug is proven to cause dangerous side effects, FDA may remove it from the market. Also, the FDA may ask the manufacturer to withdraw a drug when the drug is not used in treatment anymore. There are a number of reasons why the FDA sometimes chooses to remove a drug off the market, according to this article. Here are two of them.

Many drugs on the market cause side effects that are well documented. In fact, known side effects lead to more injuries and fatalities than unknown ones. However, some adverse effects only happen rarely which makes predicting them difficult. Normally, drugs are tested rigorously before they end up in the market allowing the more common side effects to be detected. But rare problems do not necessarily show up in these tests and dangerous drugs manage to get in the market.

Sometimes, a drug proves to be more toxic than what was previously thought. For example, Baycol (cerivastatin) was a type of a cholesterol lowering drug. It was later discovered that Baycol can cause rhabdomyolysis, a serious condition that breaks down muscle cells and can lead to kidney failure and other fatal problems. The FDA initially approved the drug because they did not discover the dangers associated with it. However, when the drug was used in higher doses and more frequently, it became apparent that it caused rhabdomyolysis more often than similar drugs. The FDA pulled the drug off the market in 2001.


A new trend in operating rooms across the United States and the world is a robot named Da Vinci. This expensive multi-armed machine was approved by the FDA nearly four years ago to assist with highly dangerous surgeries like prostate removal, heart valve replacement and the transplantation of organs. In fact, nearly 400,000 surgeries have been performed with da Vinci across the United States, which is three times the number of robot assisted surgeries four years ago.

The robotic system is controlled by a surgeon who sits at a computer screen away from the patient. Advocates of using these robots have claimed that it removes the human element of shaky hands and also decreases recovery time for surgeries with large incisions.

But now, there has been a plethora of problems being reported about the da Vinci robot. Problems include times when a robotic hand wouldn't let go of a person's tissue during a surgery, or another incident when an arm of da Vinci repeatedly slapped a patient in the face. There have also been deaths that have happened during surgeries.

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