University of Aizu

“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency said in its letter to providers. \n The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site in Japan has failed to meet quality requirements.The agency cautioned healthcare providers that future medical device shipments will be refused entry to the U.S., namely 58 specific models of laparoscopes, bronchoscopes, nasopharyngoscopes and ureteroscopes, as well as automated cleaners and reprocessing accessories.“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency said in its letter to providers. The FDA said that health systems may continue to use any devices they may already have, as long as they are not experiencing any problems—for example, if hardware has failed a leak test, that could provide a route to contamination.  In addition, the import alert does not apply to products such as replacement parts, connectors and single-use consumables that are used alongside the affected scopes.“The FDA does not recommend that procedures be canceled or delayed without discussion of the benefits and risks between the health care provider and patient,” the agency said. The regulator said it has taken several actions related to quality system requirements and compliance concerns with Olympus and its Aizu subsidiary, with its sterile endoscope manufacturing facility located in Japan’s Fukushima prefecture, and that it will continue to work with the company to implement corrective actions.  The FDA previously sent a warning letter to Aizu Olympus Co., Ltd., in November 2022, citing a lack of written procedures and documentation for certain assembly and cleaning processes. A few months later, the broader Olympus Medical Systems Corp. received a separate warning letter related to a Tokyo site that produces accessories for duodenoscopes and bronchoscopes—following complaints of cracked distal end caps, and some coming loose within a patient during a procedure.During that period, the company also received a third missive from the FDA, saying it had failed to report device failures and malfunctions within an adequate timeframe. At that time, the agency’s leadership said that “Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety.” In late 2023, the FDA issued a Class I recall designation, its most serious, to cover more than 17,600 video bronchoscopes distributed across the U.S. since 2001. No products were removed from the market or returned to the manufacturer at that time; Olympus said it had received four reports of fires sparking within patients’ lungs when the scopes were used alongside high-frequency cauterization equipment within a high-oxygen environment. 

After reports of patients experiencing arrhythmias during surgical procedures where Olympus Medical’s High-Flow Insufflation Unit, Model UHI-4, was used, the company is now recalling the device , which has been labeled as Class I. The Olympus UHI-4 is designed for insufflation of the abdominal cavity for diagnostic and operative laparoscopy, according to the company. Insufflation is the act of blowing something into the body cavity, usually CO 2 gas. UHI-4 works in conjunction with the Thunderbeat platform to eliminate smoke and mist through its adjustable smoke evacuation feature as well as a small cavity mode for endoscopic vessel harvesting procedures. Insufflation using the device allows for a quick response to gas leaks, meaning surgeons are able to remain focused on the procedure. The cylinder hose comes with a CO 2 switch-over valve enabling surgeons to change CO 2 tanks without interrupting long procedures. The company said that the decision to initiate the recall came after reviewing reports of patient injuries and one death which, according to the FDA recall entry, “may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.” Initiating the recall on Sept. 22, which was recorded on the FDA medical device recall database on Oct. 18, the company has not disclosed the total number of injury reports, potential deaths associated with the recall, or when Olympus was made aware of the safety issue. The recall effects 3,136 units in the United States, according to the FDA filing. Olympus recommends customers carefully read the Field Correction Action Letter and report complaints, including injuries associated with over insufflation during a procedure using UHI-4, to the company. This isn’t the first time in 2023 that Olympus has been in FDA’s crosshairs. In January, Olympus Medical Systems and its subsidiary, Aizu Olympus were hit with a warning letter detailing violations of the Federal Food, Drug, and Cosmetic (FD&C) Act at its manufacturing facility in Aizuwakamatsu, Fukushima, Japan, addressing compliance issues related to the reprocessing of endoscopes. In March, Olympus Medical Systems once again received a warning letter about FD&C violations, this time at its Tokyo, Japan facility. The letter reported violations including compliant handling, medical device reporting, and corrective and preventative actions.

The University of Aizu collaborated on development of the technology designed to help verify individuals’ identity and protect data integrity TOKYO--(BUSINESS WIRE)-- SIMPLEX QUANTUM, Inc. has completed registration in the United States of a patent for a system designed to accurately authenticate an individual’s electrocardiogram (ECG) waveform data. Patent US 11,500,975 B2 describes the system as an authentication device, authentication method, and computer program. Authentication is essential to protect individuals’ identity, the integrity of sensitive personal data, and the ECG technology that produces the data. Biometrics have shown promise as a next-generation authentication tool because they are difficult to circumvent. ECG signals are especially conducive because they are highly personalized and challenging to counterfeit. SIMPLEX QUANTUM developed the system with the Public University Corporation of the University of Aizu. “We are pleased to receive US registration for this patent,” says SIMPLEX QUANTUM CEO Ryu Saito. “Breakthrough ECG authentication technology complements our other innovations that advance the use of ECG data to benefit consumers, healthcare professionals, and health systems.” This patent registration follows US patent registration of artificial intelligence (AI) technology developed by SIMPLEX QUANTUM to determine heart failure stage using ECG data. SIMPLEX QUANTUM technology has not yet received US Food and Drug Administration (FDA) clearance for marketing in the US. However, with its pre-submission application to the FDA, the company has initiated the regulatory pathway to marketing of its technology as a medical device in the US. About SIMPLEX QUANTUM, Inc. Founded in 2014, Tokyo-based SIMPLEX QUANTUM develops technology in collaboration with partners including Japan’s Agency for Medical Research and Development. For more information, please visit . About the University of Aizu Established in 1993 and located in Fukushima, Japan, the University of Aizu is Japan’s first university specializing in computer science and engineering. It is an international university with approximately 40% of the faculty coming from abroad. For more information, please visit .