Olympus

The FDA labeled a recall of Olympus bronchoscopes that could lead to burns or fire Class I, the most serious kind.

Olympus reports 192 complaints related to the issue, including four injuries. The company has received no reports of death.

This recall — a correction, not a product removal — applies to Olympus bronchofiberscopes and bronchovideoscopes. The company distributed affected devices between Jan. 1, 2001, and Sept. 11, 2023 before initiating the recall on Oct. 12. In total, the recall affects 17,691 devices in the U.S.

Olympus scopes in the recall work with accessories and cameras and lights to examine or treat a person’s airways. Olympus recalled certain scopes because they may lead to burns or catch fire.

Using affected scopes could cause serious health consequences, including critical burns in a person’s airways or lungs. It could also lead to airway bleeding, trouble breathing, apnea, loss of consciousness or death. Combusti…

Olympus has initiated a voluntary field corrective action following reports of endobronchial combustion incidents involving bronchoscopes.

The field corrective action — announced Nov. 9 — is taking place after incidents occurred during medical procedures utilizing high-frequency therapy equipment in environments rich in oxygen, according to the company.

The warnings are separate from Olympus’ July field corrective action involving laser-compatible bronchoscopes tied to reports of endobronchial combustion, serious patient injury, and one death.

The new round of bronchoscope warnings came after Olympus received complaints about adverse events, some resulting in serious patient injuries. Endobronchial combustion could result in burns to the airway or lungs, necessitating additional medical intervention, prolonged procedures, extended hospital stays, intensive care, and in some cases, fatalities.

Health providers use the bronchoscope in endoscop…

Olympus announced a field corrective action in the U.S. due to over-insufflation during use of its UHI-4 high-flow insufflation unit.

The company designed UHI-4 to facilitate laparoscopic and endoscopic observation, diagnosis and treatment. It insufflates the abdominal cavity and colon, providing automatic suction and smoke evacuation.

Olympus received complaints of patients suffering complications from over-insufflation with the device. That included arrhythmias reported as “short cardiac arrests,” and gas embolism.

The company received one report of death during a surgical procedure that used UHI-4 devices.

Olympus requested in an Oct. 25 corrective action letter that customers discontinue use of the device until further notice. Customers who don’t have an alternative available or who are unable to obtain one may use the device. Olympus said it issued this direction because it considers safety and risk mitigation as “top …

The next generation of EasySuite, ES-IP is a modular, scalable, workflow-based solution. It features the Olympus digital hub and its flexibility to run current software and potential future multi-specialty applications.

“We are excited to bring the power of the Olympus Digital Hub and our digital strategy to the core of our flagship EASYSUITE System,” said Shawn LaRocco, Vice President, Global Head Customer Solutions Business Unit. “The launch of  EASYSUITE™ ES-IP system represents Olympus’ commitment to delivering intelligent integrated solutions designed to improve patient care pathways and clinical operations. With an increasing reliance on IT, it’s essential that clinicians and nurses have the right data at the right time, allowing t…

The FDA clearance covers Olympus’ GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope indicated for use in the lower digestive tract.

Olympus’s GI endoscopy systems are used by physicians to help diagnose, treat and observe diseases and disorders of the upper and lower GI tract, such as acid reflux, ulcers, Crohn’s disease, Celiac disease and colorectal cancer. According to the company, one of the most common uses of an endoscope is for screening colonoscopy, during which a physician examines the lining of the colon and removes cancerous growths. Olympus’ new imaging technologies can help physicians visualize abnormalities.

“We are thrilled that we will soon …

The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo, Japan, facility.

This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year.

According to the letter, the agency conducted an inspection of the Tokyo firm between Nov. 7, 2022, and Nov. 10, 2022. It determined that the firm manufactures endoscopes and endoscope accessories. These include single-use distal covers for duodenoscopes and single-use suction valve accessories for bronchoscopes.

FDA said the inspection revealed that these devices “are adulterated.” This means that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.

The agency said it received responses from Seiji…