Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints

Federal regulators indicate that Olympus Medical is failing to comply with good manufacturing practices for endoscopes, duodenoscopes and related accessories, and the manufacturer has failed to properly investigate complaints involving problems with the devices.

The U.S. Food and Drug Administration sent a warning letter to Olympus on March 17, following a review of findings from a November 2022 inspection of a facility in Tokyo, Japan. It is the second warning Olympus Medical Systems Corporation has received from the FDA this year, with the first warning letter issued in January 2023.

During the investigation the FDA determined the way Olympus manufactured endoscope and endoscope accessories led to adulterated devices.

Specifically, the agency indicated methods Olympus used to manufacture Single-Use Distal Covers for Duodenoscopes and Single-Use Suction Valve accessories for Bronchoscopes did not follow “good manufacturing practice requirements.”

Olympus Duodenoscope Complaints Go Unanswered

The FDA issued violations for potential breach of sterility in the packaging seal, and found that, since November 2020, Olympus has received at least 160 complaints indicating the distal end cover for its model number MAJ-2315 duodenoscopes “dropped out,” which poses a risk to patients.

The agency indicates Olympus investigated why the problem was not escalated further, instead of investigating the problem itself, why it was occurring and how to protect patients.

Instead, Olympus deemed the distal end cover problem low risk to patients and not relevant to investigate. The FDA disagrees, calling the 160 complaints an increasing trend that the company should have noticed and investigated.

The FDA considers the problem high-risk to patients, questioning why Olympus did not consider the risk of tissue injury from the devices navigating the gastrointestinal tract with an uncovered scope tip.

One complaint cited sustained “esophageal trauma” from using the duodenoscope with the distal cap problem. The same complaint noted many of the duodenoscope caps were already cracked coming out of manufacturer packaging.

Other violations include failure to establish and maintain procedures for implementing corrective and preventive action, as well as quality problems with audit reports, records and complaints.

Olympus responded to the FDA’s initial warning notice in December and February, but the new warning notice states the responses to the warnings were not adequate to address the problems. Olympus must respond to the new warning and investigate these complaints within 15 days. The FDA may require a follow-up inspection of the facility to confirm the corrective actions have been taken.

Duodenoscope Safety Concerns

Duodenoscopes are a type of endoscope used during endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, difficulties cleaning device manufactured by several different companies have resulted in a number of problems in recent years, typically involving aggressive, antibiotic-resistant “superbugs”.

Concerns about the risk of duodenoscope infections emerged about seven years ago, following a number of outbreaks at different hospitals. Investigations by health officials identified problems with the cleaning procedures provided by Olympus and other manufacturers, which may allow the devices to transfer tissue or bacteria between patients.

In response to a continuing risk of problems, the FDA issued a safety communication in April 2022, urging hospitals nationwide to change over to using disposable duodenoscopes and disposable duodenoscope parts.

FDA Promotes Use of Disposable Endoscope Components Due to Infection Risks

Questions about the safety of the devices first emerged after a duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections, which resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined at that time that the instructions sent out at the time were inadequate, and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In response to the problem, the FDA approved the first design with a disposable elevator tip, the most problematic and hard to clean part of the duodenoscope, in November 2019. Now, the agency says there are enough various disposable parts and entirely disposable duodenoscopes on the market that hospitals in the United States can, and should, transition to these devices and end use of reusable duodenoscopes with fixed endcaps.