Despite the government’s demand to create more “single-use” medical devices, the United States Food and Drug Administration (FDA) is discovering the dangers of single-use devices for use in healthcare. For example, the next-generation Olympus Duodenoscope components seemed to be an innovative safety solution, but recent FDA findings suggest otherwise.
Olympus Medical Systems, a leading duodenoscope manufacturer, received a warning letter from the U.S. FDA regarding the company’s slow response to numerous complaints about parts detaching during procedures. Some of these instances reportedly led to patient injuries.
The FDA stated that since November 2020, Olympus Medical had received about 160 complaints describing the “distal end cover” falling out during use. While the company noted that the number of complaints exceeded expectations, it failed to initiate corrective and preventive action in response to the growing trend. In some incidents, the end caps that fell off went unnoticed by the physicians who were performing the procedures or were noticed but couldn’t be retrieved, as per reports submitted to the FDA’s “Manufacturer and User Facility Device Experience (MAUDE)” database.
One customer complaint quoted by the FDA claimed that a patient experienced esophageal trauma, with tissue from the esophagus getting caught in the distal tip of the device due to cracked caps. The same customer reported that some device caps appeared cracked upon opening their packages.
response systems for potential product failures. Notably, Olympus and one of its former senior executives pleaded guilty to criminal charges stemming from their failure to report adverse events related to their duodenoscopes in 2018.
Duodenoscopes did not receive widespread attention until 2013, when officials began noticing antibiotic-resistant gastrointestinal infections in patients who had undergone procedures with these devices. Essential for endoscopic retrograde cholangiopancreatography (ERCP) and certain other pancreatic and intestinal procedures, duodenoscopes came under scrutiny in 2015 when two patients died from “superbug” infections after procedures at the University of California Los Angeles medical center, sparking national outrage.
The issue was traced back to challenges in fully decontaminating duodenoscopes after use. Although an FDA advisory committee deemed the devices inherently unsafe, the agency allowed them to remain on the market due to a lack of adequate alternatives with enhanced cleaning instructions.
The FDA also urged manufacturers to develop new models that were either fully disposable or featured disposable end caps, as cleaning these parts seemed to be the primary issue. Olympus and other manufacturers quickly received approval for their devices, and it appeared that the contamination problem was, if not completely resolved, at least diminished to an acceptable level.
The FDA’s March 15, 2023, letter not only criticized Olympus’s delay in addressing the new wave of complaints but also took issue with the company’s device packaging system. An inspection of Olympus’s manufacturing facility in Japan revealed defects in the package seal that could lead to microbial contamination. The agency also faulted Olympus for not making sufficient efforts to determine why the end caps were detaching.
As of now, no such issues have been identified with duodenoscopes produced by the other two major manufacturers, Pentax and Fujifilm. The FDA’s last warning letters to these firms, sent in 2018, concerned their alleged failure to fully comply with an FDA order to conduct surveillance studies with older products then still on the market.
Were you or a loved one harmed by an Olympus Medical Systems Duodenoscope? If so, significant monetary compensation could be recovered. Contact our national product liability law firm today to receive a free consultation and learn about your legal options.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
To find out if you or your loved one can file a civil lawsuit, call Parker Waichman LLP for a free legal consultation. Call 1-800-YOUR-LAWYER (1-800-968-7529) or use our online chat feature to speak with our attorneys, who will help you understand your legal rights and work hard to obtain the compensation you or your loved one deserves.
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation