Olympus q180v Scope

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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.

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.

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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.

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 thereafter 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.

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A tort is a civil wrongful act committed by a person or company that results in harm to another person. A mass tort is when multiple victims are injured by the same single tort.

A court will consider if a mass tort lawsuit is permissible by determining:

whether a large number of plaintiffs are involved
whether the plaintiffs are located near or far from each other;
whether the injuries sustained are similar among the plaintiffs;
whether the claims arose from the same cause (defective toy, car part, oil spill, etc.)

Defective products, such as car parts, toys, or other consumer goods.
Pharmaceutical drugs, such as those that are later linked to severe or fatal health consequences
Environmental hazards, such as polluted water sources contaminated by nearby industrial sites or an oil leak.

Thousands of lawsuits across the country may be filed with a mass tort. These lawsuits are filed in numerous federal district courts. In a mass tort, federal judges will consolidate the thousands of lawsuits into a single proceeding. One judge in a single federal district court will oversee litigation, allowing for consistent rulings and a more expeditious process for the plaintiffs.

In a mass tort, each plaintiff (injured person) has an individual claim resulting from their unique damages. In a class action, many plaintiffs are considered collectively. Similarly, in a mass tort, each individual’s claim “value” is unique to the severity of their injuries. In a class action, plaintiffs generally suffer injuries of similar severity, resulting in the same amount of compensation value.

If you have been injured or suffered illness due to a recalled drug, having an expert witnesses can be essential to proving your claim. Thomas J. Henry has spent decades building professional relationships with leading experts including:

Pharmacologists
Toxicologists
Regulatory Compliance Consultants
Forensic toxicologists
Drug Injury Causation Experts
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