The FDA on March 15 issued its third warning letter to endoscope manufacturer Olympus Medical, following a manufacturing site inspection and 160 complaints of device failure, as reported by Beckers.
The warning letter comes after a Tokyo, Japan facility inspection, where the Single-Use Distal Covers for Duodenoscopes and Single-Use Suction Valve Accessories for Brochoscopes are produced, found Olympus Medical is not accordance with federal regulations.
The violations cited by the FDA in a March 17 release include failure to evaluate user complaints of adverse events, failure to install procedures to evaluate, correct and prevent recurring quality issues, and lack of verification that preventative and corrective actions are effective.
Complaints describe the “distal end cover” “dropped out," and cracks in the cap end upon opening the device. Another complaint describes an esophageal trauma where “tissue from the esophagus was caught in the distal tip of the device.”
Other issues include sterility complications such as wrinkles or bubbles in the package seal, and while modifications were made to remedy this issue, “no re-validation of the process was made” to ensure its integrity.
According to Olympus Medical procedure, complaint investigations are required to be made within 30 days, however the investigations did not occur for two years.
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
The first warning letter was issued to Olympus Medical in November 2022.Read More >>