Olympus Endoscope Infection Lawyers

What Are Olympus Endoscopes Used For?

Olympus manufactures reusable endoscopes and related accessories that allow physicians to see inside the body, diagnose disease, take samples, remove blockages, deliver therapy, and perform minimally invasive procedures. FDA materials describe Olympus endoscope categories as including urological endoscopes, duodenoscopes, and bronchoscopes, which are used to view and access the urinary tract, gastrointestinal tract, and respiratory tract during diagnostic and therapeutic procedures.

Depending on the model and procedure, Olympus scopes may be used in:

• ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures: A duodenoscope is passed through the mouth, stomach, and into the duodenum to diagnose or treat problems involving the bile ducts, pancreatic duct, gallbladder, or liver
• Bronchoscopy: A bronchoscope allows physicians to inspect or treat the airways and lungs
• Cystoscopy and ureteroscopy: Urological scopes may be used to examine or treat the bladder, urethra, ureters, and kidneys
• Hysteroscopy: A scope may be used to evaluate or treat conditions involving the uterus and cervix
• Gastrointestinal procedures: Certain scopes help physicians evaluate the esophagus, stomach, small intestine, colon, or related structures

Many of these devices are designed to be reused. After a procedure, the device must be manually cleaned, disinfected or sterilized, dried, stored, and prepared for the next patient. The FDA has emphasized that manual cleaning before disinfection or sterilization is critical for duodenoscopes and it has also stated that the complex design of these devices can make effective reprocessing more difficult.

How Are the Medical Devices and Injuries Linked?

Olympus scope claims focus on the way reusable scopes and accessories are designed, cleaned, disinfected, and reused between patients. Duodenoscopes, for example, have small channels, moving parts, and a distal-end mechanism that can be difficult to fully clean. The FDA has stated that if a duodenoscope is not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in the scope and may lead to patient-to-patient infection transmission in rare cases.

The concern is not limited to ordinary dirt or visible debris. Some organisms can remain in small channels, crevices, seals, or hard-to-reach components after reprocessing. Researchers have reported that reprocessed duodenoscopes can still test positive for high-concern organisms and they have recommended continued efforts to improve instructions for use, human factors in reprocessing, staff training, reprocessing environments, and distal-end design.

FDA and U.S. Department of Justice (DOJ) records also provide important background for these claims. In 2018, Olympus Medical Systems Corporation pleaded guilty to distributing misbranded duodenoscopes after failing to file FDA-required adverse event reports involving serious infections, and the company was ordered to pay $80 million in fines and $5 million in criminal forfeiture. In 2023, the FDA issued a warning letter to Olympus subsidiary Aizu Olympus Co., Ltd., citing multiple violations of quality system regulations at a manufacturing facility in Japan. The violations included: (1) failure to adequately validate product designs, (2) failure to document and test manufacturing processes, and (3) failure to establish written procedures for reporting adverse events.

For the MAJ-891 Forceps/Irrigation Plug accessory used with certain Olympus endoscopes, the FDA’s recall database states that the Class I recall involved potential inadvertent retention of biomaterial when the reprocessing procedure was not performed as instructed, including not completely removing and disassembling the device. Olympus also announced a medical device advisory notice for MAJ-891 after complaints involving patient injuries and one death and advised customers to use alternative devices where available due to infection risk from improper reprocessing.