Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

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.

Affected Product

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:

• MAJ-891 Forceps/Irrigation Plug (Isolated Type)
• All lots
• UDI: 04953170063114

What to Do

• On December 18, 2024, Olympus sent all affected customers an Urgent: Medical Device Advisory Notice recommending the following actions:
  • Due to the risk of infection that may result from improper MAJ-891 reprocessing, alternatives to the MAJ-891 should be used instead.
  • Available alternative devices to the MAJ-891 for Olympus cystoscopes (CYF series) and ureteroscopes (URF series) include:
  • There are currently no alternative Olympus irrigation plugs for use with CHF and HYF endoscopes. Use an alternative scope in those situations or a non-Olympus irrigation plug provided it has been validated for use with the Olympus scope 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 (see image provided under the “Affected Product” section). The reprocessing instructions for the MAJ-891 can be found in Chapters 5 through 7 of the MAJ-891 Instructions for Use (IFU).
  • Users should also inspect the biopsy valve (MAJ-579) (see image provided under the “Affected Product” section) for damage or deformation and replace the biopsy valve if damage is identified, as instructed in the IFU. A damaged or deformed biopsy valve may impact the reprocessing efficacy.
• Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

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).

Device Use

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.

Contact Information

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.

Unique Device Identifier (UDI)

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.

How do I report a problem?

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.