Leak Causes Infection Risk in Medical Device, Prompts Product Recall, Redesign

By Drazin & Warshaw | May 4th, 2016

Olympus America, a major manufacturer of medical and surgical products, is in the process of redesigning a duodenoscope because it reportedly had a defect that caused infections during surgeries.

A duodenoscope is a long, flexible tube that allows surgeons to see inside a patient’s body during surgery. The medical device is typically used during an endoscopic retrograde cholangiopancreatography (ERCP), a procedure that makes it easier for surgeons to move past a cancerous tumor and gain access to a blocked bile duct or the pancreas.

The Olympus duodenoscope was found to pose a significant safety hazard because it was leaking fluid. Earlier this year, Olympus took action and ordered a recall of its duodenoscopes. That’s because several patients who were treated with the company’s medical device ended up with potentially deadly infections after surgery. Some estimates are as high as 25 patients who suffered infections as a result of surgeries involving the company’s duodenoscope since 2012.

Now Olympus, in accordance with an order from the U.S. Food and Drug Administration (FDA), has taken measures to fix the product defect and decrease the risk of infection during surgery. The deputy director for science in the FDA’s Center for Devices and Radiological Health recently said that the federal agency acknowledges the risk of bacterial infections when surgeons use duodenoscopes. Moreover, read the statement, the FDA is placing a priority on improving the safety of all duodenoscopes that are used during surgeries.

One example of the FDA’s emphasis on patient safety came in August 2015, when the agency ordered Olympus, Fujifilm and Hoya Corp., three major manufacturers of duodenoscopes, to conduct extensive research to determine just how safe their products are.

For further information about this product recall, see the ModernHealthcare.com article, “Olympus to Begin Voluntary Recall of Its Duodenoscopes.”

 

If you or a loved one has suffered an illness or sustained a personal injury due to use of a defective product, or as a result of a negligent doctor, you should talk to a skilled product liability and medical malpractice attorney. The NJ personal injury and product liability lawyers at Drazin and Warshaw, P.C. have more than 70 years of combined experience dealing with these types of cases. Contact us today to schedule a free consultation about your case.

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