A number of surgical procedures involving operating room equipment result in operating room injury. Although most surgeries are successful, some can go wrong and they are often not the result of the surgical team. Most common are burn injuries from OR fire, which can be caused by defective medical equipment. If you were injured during surgery and believe it was caused by a defective medical device, you should speak to an operating room injury lawyer.
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Operating Room Injuries
Operating room injury lawsuits are product liability cases where a personal injury has occurred due to defective OR equipment. A successful OR injury lawsuit must prove that the equipment was defective and directly caused injury or death. Medical device manufacturers may be liable for damages if: (1) the product has a defect in the design that causes injury and (2) the manufacturer failed to recall a product found to be dangerous.
Operating Room Fire Injuries
The Centers for Disease Control and Prevention (CDC)
reports that more than 51 million inpatient surgical operations were performed in the US in 2010. The operating room environment is considered a potential fire hazard. Statistics indicate that hospital burn injuries are increasing: A 2003 report by the Joint Commission on Accreditation of Healthcare Organizations indicated that 100 surgical fires are reported each year, resulting in up to 20 serious injuries and one or two patient deaths. By 2008, The Pennsylvania Patient Safety Reporting System reported that OR fire accidents affect between 550 and 650 patients a year. And it is believed that some OR fires are not reported. Although the FDA has set guidelines regarding hospital fire safety, hospital injury lawyers are investigating an increasing number of hospital burn lawsuits.
Causes of Hospital Fires include three factors:
An oxidizer (anesthesia products such as oxygen and nitrous oxide)
Fuel (surgical drapes, alcohol swabs, etc.)
An ignition source (lasers, electrosurgical devices such as a cautery knife, etc.)
Electrosurgical tools called "Bovies" start about 70 percent of all surgical fires. These tools use a high-frequency electric current to cut tissue or stop bleeding. About 20 percent of hospital fires are sparked by burrs, defibrillators, hot wires or light sources, while approximately 10 percent are ignited by lasers.
DaVinci Surgical Robot Injury
The daVinci surgical robot, used in many surgeries across the US, was designed to make surgery less invasive. But DaVinci robot lawsuits against Intuitive Surgical, the manufacturer, claim that flaws in the design have caused serious complications, permanent injuries and death. Most reports involve burns to internal organs and intestines, some of which were not apparent until after surgery. In February 2013, the Da Vinci system was involved in 70 patient deaths, according to Bloomberg News.
After Intuitive admitted that not all components were tested according to standards of compliance, the FDA in 2013 conducted a Class II recall of 30 components used in the technology.
A New York father claimed his daughter, who underwent a hysterectomy at a Bronx hospital, died as a result of the da Vinci surgical robot defective design. The hospital burn lawsuit claims the woman' artery and intestines were burnt due to design flaws that include un-insulated surgical arms and use of electrical current which can jump to healthy internal organs and tissue. As well, the lawsuit claims that Intuitive Surgical failed to conduct randomized studies to assess complications that may be associated with use of the da Vinci Surgical Robot.
The FDA issued a safety communication warning against the use of laparoscopic power morcellation for hysterectomy or myomectomy (uterine fibroid removal). Of concern are reports of the spread of unsuspected cancerous tissue—specifically, uterine sarcoma—during laparoscopic hysterectomy. Laparoscopic power morcellation lawsuits have now been filed by women alleging they were harmed by the use of a power morcellator during laparoscopic hysterectomy.
The Stryker ShapeMatch Cutting Guide was designed as a disposable guide to help surgeons mark and cut bones before a knee replacement operation with Stryker' Triathlon Knee System. There have been numerous reports of injury due to a defect that allowed "wider cutting ranges", believed to be responsible for prosthetics that don't fit properly or result in premature failure. The FDA in 2013 issued a Class 1 recall of the Stryker CuttingMatch Guides. A number of defective product claims against Stryker have been filed.
The 3M Bair Hugger Warming System is a Forced-Air Warming blanket medical device designed to keep patients warm during orthopedic surgery and reduce the risk of infections. But Bair Hugger lawsuits allege warming blanket injury and warming blanket infection. A number of 3M Bair Hugger injury lawsuits have been filed by patients who had hip or knee replacements and developed Deep Joint Infections. One patient who filed a Bair Hugger defective medical device lawsuit needed his leg amputated after developing infection following surgery.
Surgical Lights Injury
A personal injury was filed in July 2015 by an Oregon man claiming he was burned by powerful surgical lights during toe surgery. The Oregonian reported that the man filed an $805,000 lawsuit against the Marion County hospital. Acording to the Associated Press, in January as many as 2,100 patients may have been exposed to intense ultraviolet radiation in three operating rooms over a 14-month period. The hospital had replaced halogen lights in its operating rooms — but not filters designed to screen out UV radiation — in September 2013.
Endoscopic Procedures Injury
Endoscopic procedures have been linked to the spread of drug resistant bacteria. In 2009 the FDA began to review sterilization procedures in order to determine how best to reduce the risk of contamination. Two years later, healthcare providers were issued guidelines addressing the rise in incidents where patients contracted drug resistant bacteria following endoscopic procedures. In 2013 the CDC found a link between the use of endoscopes and the spread of carbapenem-resistant enterobacteriaceae. Further, the CDC recommended to healthcare that they disclose the risk of infection to patients considering endoscopic procedure.
The Trocar or Veress needle used in laparoscopic surgery has been linked to bowel injury, a rare but serious complication of laparoscopic surgery. The FDA in 2003 advised Trocar manufacturers and device regulators to provide better information on the inherent risks associated with trocar use, including clear, complete, and accurate trocar use information with each product sold.
Operating Room Equipment Injury Legal Help
Victims in operating room injuries involving the above OR equipment should consult with an experienced operating room injury lawyer. If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a personal injury lawyer who may evaluate your claim at no cost or obligation.
Minneapolis, MN: Lawyers and plaintiffs are awaiting an important decision in the Stockert 3T heater-cooler litigation process as the Judicial Panel Multidistrict Litigation (JPML) decides whether or not to consolidate 42 lawsuits into a single federal MDL. Plaintiffs allege the German manufactured operating room device infected some thoracic cardiovascular surgery patients with a potentially deadly strain of bacteria called Mycobacterium Chimera (M. chimaera) [READ MORE]
St. Paul, MN: Seventeen months after open-heart surgery where a Stockert 3T heater-cooler system device was used, a man died from M. chimaera and doctors associated the deadly infection with the heater-cooler unit. His wife is one of several people who, in the past few months is seeking legal action against the manufacturer [READ MORE]
Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids [READ MORE]