Olympus MAJ-891 endoscope accessory recalled due to risk of contamination, USA

United States

Olympus 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 Olympus 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. Olympus 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. Olympus 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 Olympus cystoscopes (CYF series) and ureteroscopes (URF series) should be used instead.
- There are currently no alternative Olympus 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-Olympus irrigation plug, provided it has been validated for use with the Olympus 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.

Company name: Olympus Corporation
Brand name: Olympus
Product recalled: MAJ-891 endoscope accessory
Reason of the recall: Risk of device contamination that may result from improper reprocessing.
FDA Recall date: January 30, 2025

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-medical-device-advisory-notice-use-alternative-devices-maj-891-forcepsirrigation-plug