The U.S. Food and Drug Administration has issued another warning letter to leading endoscope manufacturer Olympus Medical Systems Corp.
The letter followed a November 2022 inspection of the company’s Tokyo, Japan, facility which manufactures endoscopes and endoscope accessories. It describes additional violations of the Federal Food, Drug, and Cosmetic (FD&C) Act at the manufacturing facility.
Olympus makes disposable distal tips for duodenoscopes and single-use suction valve accessories for bronchoscopes at the facility. The inspection found the devices to be “adulterated.”
In a statement provided to MassDevice, Olympus said it was “developing a comprehensive response” to the warning letter, which will be “provided to FDA within the required timeframe.”
The warning cites several violations of the FD&C Act, including failure to evaluate user reports of adverse events and, when necessary, reporting the event to the FDA. Medical device reporting (MDR) is a post-market surveillance tool used to monitor device performance, detect potential device-related safety issues and aid in their benefit-risk assessments.
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release. “The FDA’s quality systems requirements are essential to protecting public health.”
Olympus was also cited for failure to correct and prevent recurrence of quality problems and to verify and validate the effectiveness of its preventive and corrective actions. It was found not to be “in conformity” with best practices and maintenance requirements.
Olympus received a 2020 complaint that "a patient sustained esophageal trauma" and "tissue from the esophagus was caught up in the distal tip of the device," which was associated to “cracked caps,” according to the warning letter. Its responses to the allegations were deemed “not adequate.”
Additionally, the letter states that since November 2020 Olympus Medical has received approximately 160 complaints describing that distal end covers “dropped out.” Olympus, according to the FDA, has failed establish and maintain procedures for implementing corrective and preventive action.
“The FDA will continue to ensure that Olympus fully addresses the violations described in the warning letters,” the news release states.
The warning is the third issued to Olympus by the FDA in less than six months. The previous two involved violations that included failure to adhere to MDR requirements and quality systems regulations.
The FDA, recognizing contamination issues and other adverse events associated with flexible endoscopes, has released updates communications in recent years relating to reprocessed duodenoscopes, bronchoscopes and urological endoscopes. Among their recommendations: transition to disposable components or to innovative single-use endoscopes to facilitate or eliminate the need for reprocessing.