Olympus Q180V Scope
REPRESENTING VICTIMS OF UNSAFE OLYMPUS Q180V SCOPES
Duodenoscopes are flexible tubes that are sent through the mouth, throat, and stomach to access the top of the small intestine. The scopes are traditionally used during a procedure to diagnose and treat pancreas and bile duct issues called endoscopic retrograde cholangiopancreatography (ERCP). Olympus Corp. manufactures the vast majority of scopes used in the United States.
More than a half million ERCP procedures take place each year in the United States. Most of these life-saving procedures are completed without severe complications. However, in 2013, the Centers for Disease Control and Prevention (CDC) alerted the Food and Drug Administration (FDA) about a link between these scopes and a multi-drug resistant bacteria.
The FDA has opened an ongoing investigation into duodenoscopes and their link to life-threatening infections caused by the bacteria.
WHAT IS CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE)?
Carbapenem-Resistant Enterobacteriaceae (CRE) is an antibiotic resistant bacteria that is most often observed in patients with compromised immune systems. These infections typically occur in patients in hospitals, nursing homes, and other healthcare settings. Ventilators, catheters, and long courses of certain antibiotic medications can increase the risk of developing CRE. Unfortunately, CRE infections are extremely deadly. Due to their difficult nature to treat, CRE infections contribute to death in 50 percent of patients that contract the infection.
CRE OUTBREAK IN SOUTHERN CALIFORNIA
One of the largest documented cases of a CRE infection outbreak occurred at the UCLA Ronald Reagan Medical Center between October 2014 and January 2015. An estimated 180 patients that underwent duodenoscope procedures were exposed to the deadly bacteria, seven of which were infected. Two deaths were confirmed to be linked to a CRE infection.
At another hospital in Pasadena, 16 patients were infected by the bacteria. Sadly, 11 people would die from the infection.
Following the outbreak, the FDA issued a safety communication regarding cleaning and disinfecting instructions for reusable duodenoscopes.
MODIFIED DUODENOSCOPE LINKED TO SAME DEADLY BACTERIA
According to a report filed by the FDA, five patients in a foreign medical facility underwent procedures with a duodenoscope and contracted the same deadly bacteria that had infected hospitals in the United States. However, the duodenoscope used in this case was Olympus’ remodel of their original Q180V scope. In January 2016, Olympus issued a recall on the current model, stating that a new model with a more easily cleanable mechanism would be replacing them. Alongside the new model would be new cleaning procedures as well.
Olympus attempted to correct the mechanism previously in 2010, but investigations revealed that biological material and bacteria could still enter the internal channel of the scope and remain present there after following the prescribed cleaning instructions.
According to the Los Angeles Times, Olympus knew of potential flaws after an outbreak occurred in the Netherlands. In addition, the Japan-based company did not alert American hospitals or the FDA regarding the potential design flaws of their scope until after the Southern California CRE outbreaks.
CONTACT AN EXPERIENCED DEFECTIVE MEDICAL DEVICE LAWYER
If you or a loved one developed an infection after a duodenoscope procedure, contact Thomas J. Henry. Duodenoscopes, including Olympus’ Q180V, have been linked to spreading an antibiotic-resistant super bug that can cause life-threatening infections. Our product liability attorneys are experienced in handling dangerous pharmaceutical drug and medical device cases across the United States. Attorneys are available 24/7, nights and weekends to evaluate your claim. Don’t wait — call us today for a free legal consultation.