FDA Faults Next-Gen Olympus Duodenoscopes

If you thought the introduction of single-use duodenoscope components had made these devices safe, the FDA has some unwelcome news for you.

The agency recently sent a warning letter to Olympus Medical Systems, one of the top duodenoscope manufacturers, upbraiding the company for its sluggish response to a slew of complaints about parts coming off during procedures. In some cases, it appeared that patients suffered injuries, although no deaths were cited.

“Since November 2020, Olympus Medical has received approximately 160 complaints describing the ‘distal end cover’ [having] ‘dropped off'” during use, the FDA wrote. “Your firm performed trending and identified that number of complaints was above the expected numbers for that type of complaint. However, your firm did not consider this increasing trend of complaints to be a quality data input to initiate a corrective and preventive action.”

The FDA also quoted one customer complaint saying that “a patient sustained esophageal trauma” and “tissue from the esophagus was caught up in the distal tip of the device,” which the user attributed to “cracked caps.” The same customer also complained that some of the device caps appeared cracked upon opening their packages.

Moreover, that complaint was submitted to Olympus in November 2020, but the company didn’t investigate it until last year, even though FDA regulations require investigations within 30 days. The FDA went on to cite a range of alleged defects in the company’s quality control, recordkeeping, and systems for responding to potential product failures — and not for the first time. In fact, the company and a former senior executive pleaded guilty in 2018 to criminal charges stemming from the company’s failure to report adverse events associated with its duodenoscopes.

Until 2013, duodenoscopes were among the thousands of medical devices used daily without attracting widespread attention. That year, officials started noticing antibiotic-resistant gastrointestinal infections in patients in whom duodenoscopes had been used. These devices are required for endoscopic retrograde cholangiopancreatography (ERCP) and certain other pancreatic and intestinal procedures. In 2015, it was reported that two patients died from “superbug” infections after undergoing duodenoscope procedures at the University of California Los Angeles medical center, triggering a national uproar.

It quickly became clear that the problem stemmed from difficulty in fully decontaminating the duodenoscopes after use. Although an FDA advisory committee concluded that the devices were inherently unsafe, the agency determined there was no adequate substitute and allowed them to remain on the market, albeit with beefed up instructions for cleaning.

The agency also encouraged manufacturers to develop new models that were either fully disposable or came with disposable end caps, cleaning of which seemed to be the main problem. Devices from Olympus and other manufacturers were OK’d in short order, and it appeared that the contamination problems was, if not 100% solved, at least reduced to an acceptable level.

Besides Olympus’s alleged failure to respond to the new batch of complaints in a timely fashion, the FDA’s March 15, 2023, letter also criticized the company’s system for packaging the device. An inspection of the firm’s manufacturing facility in Japan identified defects in the package seal that could allow microbial contamination. The agency also faulted Olympus for not trying hard enough to determine why the end caps were falling off.

No such problems seem to have been identified as of yet for duodenoscopes made by the other two major duodenoscope manufacturers, Pentax and Fujifilm. The FDA’s last warning letters to those firms were in 2018 and involved their alleged failure to comply fully with an FDA order to conduct surveillance studies with older products then remaining on the market.