Olympus Advises on Alternative Devices for MAJ-891 Forceps

Olympus Issues Advisory Notice on MAJ-891 Forceps

Olympus Corporation has recently shared important information regarding the Forceps/Irrigation Plug, specifically the MAJ-891 model. This advisory highlights the risks associated with using this device, particularly focusing on the potential for contamination due to insufficient reprocessing. Such issues have raised concerns following reports of adverse events among patients using this device.

Understanding the MAJ-891 Device

The MAJ-891 is an essential accessory for various Olympus endoscopes, including cystoscopes, ureteroscopes, choledochoscopes, and hysteroscopes. Its primary role is to facilitate both irrigation and the use of therapeutic accessories during endoscopic procedures. It's worth noting that this accessory was discontinued in 2022 in the U.S. market, although some customers may still have the device in their possession and use it.

Safety Concerns and Recommendations

Due to the serious nature of the reported incidents, which included patient injuries and even a fatality, Olympus has taken the step of proactively notifying customers. In their communication, they emphasized the paramount importance of following reprocessing protocols thoroughly to mitigate risks associated with the device. Improper handling can lead to exposure to contaminated equipment, posing severe health risks, including infections.

Alternative Device Recommendations

To ensure patient safety, Olympus advises customers to make use of alternative devices if available. Specifically, for Olympus cystoscopes and ureteroscopes, alternative devices from the Olympus range should be utilized instead of the MAJ-891. However, in the context of choledochoscopes and hysteroscopes, users may need to consider other non-Olympus irrigation plugs, provided these have been validated for use by their respective manufacturers.

Proper Reprocessing Guidelines

Caution must be exercised when no alternatives to the MAJ-891 are at hand. Olympus stresses the necessity of adhering to reprocessing guidelines rigorously. This includes detaching the MAJ-891 from the endoscope and disassembling it properly before cleaning, disinfecting, or sterilizing.

Reporting Issues and Feedback

Patients and healthcare providers experiencing issues or adverse reactions related to the MAJ-891 are encouraged to report these incidents. Feedback can be directed to the FDA's MedWatch program, where reports can be submitted online, providing crucial information that could help in improving device safety.

About Olympus Corporation

Olympus, with over a century of commitment to improving lives, focuses on delivering innovative medical technologies. The company aims to enhance patient care through state-of-the-art solutions that empower healthcare professionals for early diagnosis and treatment. With their global presence, Olympus continues to strive for excellence in the medical field, ensuring safety and optimal outcomes for patients worldwide.

Frequently Asked Questions

What led to the advisory notice from Olympus?

Olympus issued the advisory due to reported risks of contamination and associated adverse events involving the MAJ-891 device.

What does the MAJ-891 device do?

The MAJ-891 is an accessory for various Olympus endoscopes, allowing irrigation and therapeutic procedures during endoscopic exams.

Are there alternative devices to the MAJ-891?

Yes, Olympus recommends using alternative devices for cystoscopes and ureteroscopes while suggesting non-Olympus plugs for choledochoscopes and hysteroscopes.

How should the MAJ-891 device be reprocessed?

Reprocessing guidelines emphasize careful detachment and disassembly of the MAJ-891 before cleaning and sterilizing to prevent contamination.

How can issues with the MAJ-891 be reported?

Issues can be reported via the FDA's MedWatch program, which accepts online submissions regarding adverse events involving medical devices.

About The Author

Hi there, As a writer and financial specialist, Henry Turner is passionate about guiding people through the complex world of finance. Having worked in finance for many years, I am an expert at simplifying difficult financial ideas into understandable, useful insights for my blog and articles. My goal is to arm you with the confidence and information you need to make wise financial choices.

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