Michael Brassloff was 71 years old when he underwent surgery to remove a benign tumor at Thomas Jefferson University Hospital. During the procedure, the two-millimeter tip of a carbon dioxide-cooled laser probe snapped off after it was inserted through a hole in Mr. Brassloff's skull. As a result, the pressurized carbon dioxide drilled directly into Mr. Brassloff's brain. The force was eight times more powerful than that of a nail gun.
Posts tagged "medical device defect"
The U.S. Food and Drug Administration (FDA) issued another warning in regards to artery clearing tools. The devices are part of a new system used to open constricted arteries to help blood flow via cutting plaque from artery walls. In September. the FDA reported an incident where a wire piece from the component broke off and punctured a blood vessel, resulting in the patient's death. Two similar fatalities have also been reported in relation to the defective product. Several additional incidents have prompted emergency surgeries to retrieve dislocated parts. In one surgery the debris was unable to be extracted. Marlborough based Boston Scientific, the product manufacturer, issued a recall on October 9th.
U.S. District Judge Joseph Goodwin recently said that juries may find C.R. Bard, Inc. liable for billions of dollars in damages due to injuries consumers suffered from Bard's defective vaginal mesh-implants.
The orthopedic unit of Johnson & Johnson recently announced that it was phasing out production of all-metal hip replacement, a move reflecting an industry wide trend to abandon the once widely used implants because of high early failure rates.
According to a review by the Bloomberg News, robot systems made by Intuitive Surgical Inc. (ISRG) are linked to at least 70 deaths since 2009. The lawsuits being filed in the last 14 months are now adding new details about dangerous complications involving the da Vinci robots made by Intuitive.
Last week, a South Dakota jury ordered Johnson & Johnson to pay a woman $3.35 million for failing to adequately warn her doctor of the potential dangers of a vaginal mesh implant and for misrepresenting the product in brochures. The verdict marks the first among 1,800 vaginal mesh cases currently pending in New Jersey against Johnson & Johnson and its subsidiary, Ethicon.
According to a recent study, hip replacements are more likely to fail in women than in men. Researchers found that although the overall risk of implants failing is low, women were 29 percent more likely than men to need a repeat hip replacement surgery within the first three years. The study, which was funded by the U.S. Food and Drug Administration (FDA), was one of the largest studies of its kind in U.S. patients.