The March 15 letter came after an inspection of an additional facility in Tokyo, which cited numerous violations including failure to evaluate user reports of adverse events and failure to correct or prevent recurrence of quality problems, according to a March 17 FDA release.
The FDA has made ongoing efforts to address Olympus’ compliance issues related to reprocessing endoscopes, which are medically necessary devices used to diagnose certain conditions such as some cancers of the digestive tract. Since November 2020, the FDA said Olympus received 160 complaints that the end cover had “dropped out,” allegedly causing damage to the patients. Customers attributed the events to cracked caps, saying they had seen “a few already cracked when coming out of the packaging.”
“Olympus’s continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the release.
Inspectors also found concerns related to device sterility. Wrinkles and air bubbles in the package seal lead Olympus to modify its equipment, but “no revalidation of the process was made,” according to the warning letter.
This is the third warning letter Olympus has received from the FDA since November 2022.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.