One of the largest manufacturers of medical devices in the United States is hard at work on a redesign of the company’s duodenoscope after multiple people reportedly suffered dangerous infections as a result of using the defective device.
A duodenoscope is an important medical device that doctors can use to perform an endoscopic retrograde cholangiopancreatography (ERCP), a procedure that makes it easier for surgeons to see inside the pancreatic and biliary ducts. The invasive procedure is often necessary when a patient’s ducts are obscured by the presence of cancerous tumors.
In early 2016, Olympus issued a product recall of its duodenoscope. The recall was deemed necessary after several infection incidents were linked to the medical product. Even under the best of circumstances and conditions, a duodenoscope can increase the likelihood of a patient sustaining a dangerous bacterial infection because the device is notoriously difficult to disinfect. The risk of infection was even higher for patients who underwent ERCPs using Olympus duodenoscopes because the device reportedly leaked fluid, causing more than 25 infection incidents in the past four years.
Before Olympus could issue the newly designed medical device, it had to get approval from the US Food and Drug Administration (FDA). Now that the FDA has finally signed off on the new product design, Olympus can begin manufacturing and distributing the duodenoscopes to hospitals and doctors across the country. The company presumably hopes that this will limit the potential for product liability lawsuits in the future, while doctors and hospitals are surely hoping that they will not be exposed to medical malpractice lawsuits due to failure to properly use the medical devices.
For more information about this medical product recall, access the ModernHealthcare.com article, “Olympus to Begin Voluntary Recall of Its Duodenoscopes.”
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