infection from one patient to another via the scope procedure. We are not discussing some microscopic organism, but rather a visible gunk of matter. Had this been on the outside or had borescopy been required as part of the instructions for use, it would have been detected and taken out of service.
WHO IS RESPONSIBLE?
The thousand-pound gorilla in the endoscope market is Olympus. They have secured the number one market share in respiratory and GI, while holding the number two market share in urology. Their financials disclose approximately $ 6.3 billion in revenue for 2025.
Olympus’ reign at the top of the endoscopic market has not been without controversy. In 2018,“ Olympus Medical Systems and a former top executive pleaded guilty... to federal charges of failing to file adverse event reports about serious infections linked to the company’ s scopes.” The company agreed to pay $ 85 million dollars in a plea deal. The former executive received a small fine, coupled with a year of probation.
In January 2023, the FDA’ s Center for Devices and Radiological Health( CDRH) issued two warning letters to Olympus Medical Systems and one of its subsidiaries related to the reprocessing of endoscopes. The CDRH reported that despite
being in extensive and ongoing effort with Olympus to address compliance issues, medical device reporting requirements and quality system requirements were not being met. The FDA went on to impose an import ban on 58 different models of endoscopes manufactured by Olympus on June 24, 2025.
MOVING FORWARD
There is on-going debate in the medical and scientific community about where to go next. Single-use devices have existed for a number of years, though opponents cite the medical-grade waste and expense of such devices. What is clear, however, is that people must be aware of the risks of these devices. We, as attorneys, must be vigilant in informing our friends, families, and clients of their rights when they are injured by one of these devices. Unfortunately, many doctors are unaware of the statistical risks associated with using these defective products. As the medical community and litigation march forward, we can only hope that manufacturers implement safer products for us all.
Caleb Cunningham is an attorney at Levin Papantonio who focuses on mass torts. Kelsey Stokes is a senior attorney at The Lanier Law Firm.
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