Contaminated Reusable Device Linked to 120 Injuries and One Fatality Raises Serious Safety Concerns
The U.S. Food and Drug Administration (FDA) has issued its most serious recall classification—Class I—for the Olympus forceps/irrigation plug model MAJ-891, an accessory used with certain endoscopes. The recall follows reports of 120 injuries and one death tied to improper reprocessing of the device. Despite being discontinued in 2022, many healthcare providers have continued using the device, unaware of the risks posed by contamination. Olympus first notified medical providers in December 2024, advising them to stop using the device and seek safer alternatives when possible. The FDA’s formal recall notice now reinforces the urgency of the issue, warning that improper sterilization of the device can lead to severe infections, sepsis, or death.
Olympus Endoscope Accessory Recall and FDA Warning
Olympus has faced increasing scrutiny over the safety of its medical devices, particularly those used in endoscopic procedures. The MAJ-891 forceps/irrigation plug attaches to the instrument channel port of certain Olympus endoscopes, enabling irrigation and allowing for the use of additional accessories. The problem arises when the device is not properly disassembled and cleaned before reuse. If biomaterial from previous procedures remains trapped inside, it can introduce harmful bacteria into a patient’s body, leading to severe infections.
The recall affects over 30,000 devices distributed across the U.S., highlighting the widespread nature of the problem. The FDA’s Class I designation indicates that continued use of the device poses a high risk of serious injury or death. In response to these concerns, Olympus has advised medical providers to use alternative devices for cystoscopes and ureteroscopes. However, no Olympus-branded replacement exists for choledochoscopes and hysteroscopes. In cases where no safe alternative is available, the company has urged providers to adhere strictly to cleaning and disinfection guidelines.
The contamination risks associated with endoscopes have been an ongoing concern for the FDA. In recent years, Olympus has recalled multiple devices due to safety hazards, including bronchoscopes prone to combustion and abdominal insufflation devices linked to malfunctions. The FDA has also issued multiple warning letters regarding Olympus’ quality control failures, particularly concerning inadequate sterilization procedures for its reusable medical instruments.
How Patients Are Harmed by the Contaminated Endoscope Accessory
Patients undergoing endoscopic procedures expect medical equipment to be sterile and safe. When a reusable device is not properly cleaned, it can introduce dangerous bacteria into the body, leading to severe infections. Patients affected by the MAJ-891 recall have experienced complications such as bloodstream infections, sepsis, and in at least one confirmed case, death.
Sepsis is one of the most serious risks linked to contaminated medical devices. It occurs when an infection spreads into the bloodstream, triggering a life-threatening immune response. Patients who develop sepsis often require hospitalization, intensive care, and, in some cases, life support. Even if a patient survives, long-term health complications such as organ damage and chronic pain can result from the infection.
For individuals with compromised immune systems or underlying health conditions, exposure to a contaminated endoscope accessory can be even more dangerous. Cancer patients, transplant recipients, and individuals with autoimmune diseases are especially vulnerable to infections, making them more likely to suffer severe complications if exposed to contaminated medical instruments.
The failure to properly sterilize medical devices also raises ethical concerns about patient safety and the responsibilities of healthcare providers. Hospitals and surgical centers rely on manufacturers to provide reliable instructions for cleaning and maintaining medical equipment. If a device cannot be adequately cleaned due to design flaws, it should not be used in patient care. The continued use of the MAJ-891 despite known risks has placed patients in unnecessary danger.
Legal Rights of Victims and the Lawsuit Process
Patients harmed by Olympus’ defective endoscope accessory may be eligible to file a product liability lawsuit against the manufacturer. When a medical device is found to be dangerous due to design flaws, manufacturing defects, or inadequate safety warnings, victims have the right to seek financial compensation for their injuries.
The legal process begins with an investigation into the patient’s medical records to establish a link between the contaminated device and the harm suffered. Attorneys work with medical experts to analyze the sterilization failures and determine whether the infection resulted from improper cleaning of the Olympus accessory. Once sufficient evidence is gathered, a formal lawsuit is filed against Olympus, outlining the allegations and seeking damages.
Lawsuits involving defective medical devices often proceed through discovery, where both sides exchange evidence, including internal company documents, expert testimonies, and patient medical histories. If Olympus is found liable for failing to ensure the device’s safety, the company may be required to compensate victims for their medical expenses, lost income, pain and suffering, and other damages.
Many product liability cases settle before trial, but in some instances, litigation is necessary to hold the manufacturer accountable. A skilled attorney can help victims navigate this process and maximize their compensation.
Why Legal Representation Is Essential
Defective medical device lawsuits can be complex, requiring a thorough understanding of product liability law, FDA regulations, and medical evidence. Olympus is a major medical device manufacturer with extensive legal resources, making it difficult for injured patients to take on the company alone. An experienced attorney can investigate the case, consult medical experts, and build a strong argument demonstrating Olympus’ responsibility for the injuries caused by its product.
Victims of medical device failures should not bear the financial burden of medical treatments, lost wages, and ongoing health complications alone. A lawsuit can provide much-needed compensation to cover hospital stays, surgical interventions, and rehabilitation costs.
Compensation Available in a Product Liability Lawsuit
Victims of the Olympus MAJ-891 endoscope accessory recall may be entitled to various forms of compensation, including:
- Medical Costs: Reimbursement for hospital stays, surgeries, and ongoing treatment for infections caused by the contaminated device.
- Lost Wages: Compensation for time missed from work due to illness and recovery.
- Pain and Suffering: Damages for physical pain, emotional distress, and diminished quality of life.
- Punitive Damages: In cases where Olympus’ negligence was particularly egregious, additional damages may be awarded to punish the company and prevent future misconduct.
If you or a loved one suffered an infection, sepsis, or other complications linked to the Olympus MAJ-891 endoscope accessory, you may be entitled to significant compensation. The national product injury law firm Parker Waichman LLP is committed to holding negligent medical device manufacturers accountable and fighting for justice on behalf of injured patients.
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