This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
The FDA is aware that Olympus has issued a letter to affected health care providers recommending the forceps/irrigation plug accessory to certain endoscopes be removed from use related to a potentially high-risk device issue:
Patient infection as a result of exposure to a contaminated device can occur when reprocessing of the MAJ-891 Forceps/Irrigation Plug is improper and/or incomplete, such as not disconnecting the MAJ-891 from the endoscope and disassembling it before reprocessing. This exposure could result in patient injury including infection, urinary tract infection, or sepsis, and, in some cases, could result in death. These harms may require inpatient hospitalization/monitoring, and treatment with oral or intravenous antibiotics.
Olympus has reported 120 injuries and 1 report of death due to infection following procedures in which the MAJ-891 was used with a cystoscope (CYF scope).
The MAJ-891 is 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 US market.
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Olympus's Technical Assistance Center at 1-800-848-9024, option 1.
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.