Olympus Endoscope Components Linked to 120 Patient Injuries and 1 Death, FDA Warns

Federal health officials are warning that improper cleaning of accessories for Olympus endoscopes could result in serious patient infections, potentially leading to death.

The U.S. Food and Drug Administration (FDA) issued an alert for Olympus MAJ-891 Endoscope forceps/irrigation plug components on December 23, following one death and 120 injuries reported in connection with the endoscope accessory problem.

An endoscope is a device used to allow doctors to see inside the body during certain medical procedures. The MAJ-891 forceps/irrigation plug accessory attaches to the channel port of some Olympus Endoscopes, including cystoscopes, ureteroscopes, choledochoscopes and hysteroscopes. The part allows both irrigation and the use of endo-therapy accessories but was discontinued in the U.S. in 2022.

FDA officials determined that when the MAJ-891 is not properly cleaned, sanitized or disinfected after a patient procedure, such as when it is not fully disconnected from the device before cleaning, patients can suffer injuries like infections, urinary tract infections, sepsis, and in some cases death.

On December 18, Olympus sent letters to healthcare providers recommending the MAJ-891 forceps/irrigation plug be removed from use due to the risk of infection. However, there are currently no alternative Olympus forceps/irrigation plugs for use with CHF and HYF endoscopes, so the company recommends alternative endoscopes be used instead, or non-Olympus irrigation plugs should be used if compatible with the Olympus scope.

In particular, the letter recommended that the Luer-Split model MAJ-2092 + Seal-Port and the Adjustable Biopsy Port Seal Y-Adapter model BPS-Y be used in place of the MAJ-891.

If no alternatives are available, healthcare providers should take special care to follow cleaning and sanitizing instructions for both the endoscopes and the forceps/irrigation plug. This includes focusing dedicated attention when detaching the plug from the instrument channel port of the endoscope and disassembling it fully before it is cleaned, disinfected or sterilized.

Customers should also inspect the biopsy valve for damage or deformation and replace the valve if damage is identified.

The FDA warns that patients who suffer infections linked to the MAJ-891 may need to be hospitalized and monitored for symptoms. They may require treatment with oral and intravenous antibiotics to avoid life-threatening conditions. The warning involves all lots of MAJ-891 Forceps/Irrigation Plug (isolated type) with unique device identifiers: 04953170063114.

Customers can contact Olympus with any questions or problems with the device at 800-848-9024. Customers should also report any adverse side effects linked to the use of the Olympus Endoscope MAJ-891 Forceps/Irrigation Plug to the FDA’s MedWatch Adverse Event Reporting System.

The alert is part of a pilot program recently implemented by the agency to warn the public about dangerous risks associated with medical devices before an official recall is announced.

When the agency becomes aware of a potentially high-risk device that may cause injuries to patients, the FDA will now alert the public in advance of an official recall. This effort is meant to help prevent unnecessary injuries and deaths.

Ongoing Olympus Device Quality Issues

This isn’t the first time Olympus has experienced quality issues with medical devices.  In March 2023, the FDA issued a warning letter after the company failed to address quality issues linked to repeated problems with duodenoscopes.

The issue put patients at risk of infections and led to 160 patient complaints. It also prompted industry-wide changes to duodenoscope designs.

Another safety warning issued by the FDA in 2022 concluded that nearly 7% of reusable duodenoscopes carried high-risk bacteria even after being cleaned. The warning helped lead to an industry-wide transition to disposable duodenoscopes due to device design problems.