FDA Approves Olympus Scope Modifications Intended to Reduce Infection Risk

Categories: Medical device litigation

Ohio's Defective Medical Device Attorney - Borgess Law, LLC

On January 15, 2016, the U.S. Food and Drug Administration (FDA) cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. (1/15/16 FDA News Release)  Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair.

According to the FDA News release, duodenoscopes are used in more than 500,000 procedures each year as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. While these devices play an important role in the treatment of patients, there is evidence that some have been associated with the transmission of infectious agents, including antibiotic-resistant infections.

Specifically, the elevator channel sealing mechanism has been modified to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.

As also described in the FDA News release:

In March 2014, the FDA notified Olympus that they needed to submit a premarket notification, called a 510(k), for their “closed” elevator channel model, which had never been cleared for marketing. In a letter sent to Olympus, the agency stated that design changes to this model from previous models, which resulted in a “closed” elevator channel rather than an “open” elevator channel, were significant and impacted the safe use of the device.

For more information, or if you or a loved one suffered an infection following a procedure with a duodenoscope, contact Pharmaceutical/Medical Device Litigation Attorney Pamela A. Borgess of Borgess Law, LLC at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law, LLC by submitting an online inquiry or emailing Attorney Borgess directly at [email protected].  Borgess Law, LLC never charges a fee for an initial consultation.