The law firm of James F. Humphreys & Associates, L.C. believes you have the right to assume the devices used for your medical procedures are sanitized and safe to use. Unfortunately, this was not the case with some endoscope/duodenoscope procedures, due to the design flaws of the device and the failure of the manufacturer to inform regulatory agencies of the resulting health risks.
Duodenoscopes are flexible, camera devices used to diagnose and treat problems with the small intestine, pancreas and bile ducts. These devices are used in half a million potentially life-saving procedures every year, providing medical providers with a low risk method for seeing inside the digestive tract. However, if not properly sanitized, these devices can become a vehicle for the spread of deadly bacteria from patient to patient.
Pantex & Olympus Duodenoscope
Unfortunately, the spread of drug resistant bacteria is exactly what happened with the Pantex and Olympus Duodenoscopes. Both duodenoscopes had flaws in the design that made the devices unsafe for use due to bacteria build-up, even after cleaning recommendations were followed. The FDA was aware of these unsanitary design flaws and worked with manufacturers to ensure that their devices were safe for use.
One implicated device manufacturer, Pantex, voluntarily recalled its product from the market in 2018, issued design changes and cleaning recommendation changes and relaunched the device with FDA clearance.
On the other hand, Olympus, another manufacturer, failed to notify regulators of its knowledge that patients were developing super infections. Manufacturers are legally required to notify the FDA within 30 days of discovering a problem, but Olympus did not report the serious issue for three years.
If you or a loved one developed a life threatening infection after a duodenoscope procedure, James F. Humphreys & Associates, L.C. is prepared to fight big manufacturers like Olympus for your right to compensation. Receive a free consultation with us today.
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Although there have been reported injuries with this device, the FDA has not withdrawn its approval at this time. Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.