Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Olympus Corporation has issued a voluntary Advisory Notice regarding its MAJ-891 Forceps/Irrigation Plug, a medical device accessory used in certain endoscopes, due to the risk of contamination that could result from improper reprocessing. The MAJ-891, which was discontinued from the U.S. market in 2022, has been linked to patient injuries, including one fatality, arising from exposure to contaminated devices.
The MAJ-891 accessory, which is used with Olympus cystoscopes, ureteroscopes, choledochoscopes, and hysteroscopes, allows for irrigation and the use of endo-therapy accessories. Olympus has urged U.S. healthcare providers to use alternative devices when possible for cystoscopes and ureteroscopes, as no direct replacements are available for choledochoscopes and hysteroscopes. If alternatives are unavailable, the company stresses the importance of carefully following reprocessing instructions to prevent contamination.
The advisory comes after Olympus received complaints about adverse events linked to improper reprocessing of the MAJ-891, which could lead to infections in patients. Olympus first notified affected customers in December 2024 and has recommended that any remaining MAJ-891 devices be carefully disassembled before cleaning, disinfecting, or sterilizing.
For further assistance, Olympus has provided a contact line at 800-848-9024 and an email for reporting complaints. Healthcare professionals are also encouraged to report adverse events to the FDA’s MedWatch program.
