CENTER VALLEY, Pa., (January 29, 2025) – ³ÉÈËBÕ¾ Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.
The MAJ-891 is an endoscope accessory attached to the instrument channel port of certain ³ÉÈËBÕ¾ endoscopes, including cystoscopes (CYF series), ureteroscopes (URF series), choledochoscopes (CHF series), and hysteroscopes (HYF series) to allow both irrigation and the use of endo-therapy accessories. The MAJ-891 was discontinued in 2022 from the U.S. market. The MAJ-891 is a reusable device and customers that purchased the device prior to 2022 may still be using this accessory.
³ÉÈËBÕ¾ assessed the issue after receiving complaints of adverse events involving patient injuries and one death. The potential harm of improper and/or incomplete reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device, which could result in patient injury, specifically, infection.
³ÉÈËBÕ¾ notified U.S. customers about this matter by letter on December 18, 2024, recommending the following actions:
- Due to the risk of infection that may result from improper MAJ-891 reprocessing, available alternative devices to the MAJ-891 for ³ÉÈËBÕ¾ cystoscopes (CYF series) and ureteroscopes (URF series) should be used instead.
- There are currently no alternative ³ÉÈËBÕ¾ irrigation plugs for use with choledochoscopes (CHF series) and hysteroscopes (HYF series). Customers are advised to use an alternative endoscope in those situations or a non-³ÉÈËBÕ¾ irrigation plug, provided it has been validated for use with the ³ÉÈËBÕ¾ endoscope by the plug manufacturer.
- If no alternative for the MAJ-891 is available, it is important to closely follow the reprocessing instructions for both the endoscope(s) and the MAJ-891 Forceps/Irrigation Plug, especially detaching the MAJ-891 from the instrument channel port of the endoscope and disassembling before it is cleaned, disinfected or sterilized.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
For information or to report a problem, please contact the ³ÉÈËBÕ¾ Technical Assistance Center at 800-848-9024, Option 1 or email complaints@olympus.com.
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At ³ÉÈËBÕ¾, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, ³ÉÈËBÕ¾ has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Visit olympusamerica.com for more information.