FDA hits Olympus with warning letters after factory inspections from qocsuing's blog

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.To get more news about Industrial Videoscope, you can visit seesemborescopes.com official website.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical endoscope manufacturing operations in Hachioji-shi, Tokyo, Japan.

FDA Center for Devices and Radiological Health (CDRH) Director Dr. Jeff Shuren said the agency and Olympus have “extensive and ongoing efforts” to address compliance issues related to the reprocessing of endoscopes.

“However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements,” Shuren said in a statement. “During recent inspections, CDRH determined that Olympus did not meet requirements to assure the quality and performance of the devices such as adequate testing and documentation of the device assembly process. In addition, Olympus did not develop MDR procedures, and did not submit MDRs within the required timeframes.”

More about the warning letter
Olympus makes, among many other products, surgical and gastrointestinal endoscopes and automated endoscope reprocessors. Endoscopes can be reused if appropriately cleaned and disinfected or sterilized to remove bacteria that could cause harmful or even fatal infections.

In its warning letter to Olympus Medical Systems, the FDA said the manufacturer conducted a device recall after receiving complaints that its uretero-reno fiberscope and uretero-reno videoscope malfunctioned while in use, but failed to notify the FDA as required by law. According to the FDA, Olympus responded with a promise to improve its MDR reporting process and train staff. The FDA said it could not determine the adequacy of that ongoing effort until its conclusion.