Source: US Department of Health and Human Services – 3
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed.
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:
MAJ-891 Forceps/Irrigation Plug (Isolated Type)
All lots
UDI: 04953170063114
Full Listing of Olympus Endoscopes compatible with the MAJ-891 and Compatible Alternative Devices to MAJ-891
Scope Series
Model Number
Model Name
Compatible with MAJ-2092
Compatible with BPS-Y
Cystoscope (CYF Series)
CYF-240
CYF-240 Flexible Video CystoNephroscope
No
Yes
Cystoscope (CYF Series)
CYF-5
CYF-5 CYSTOSCOPE EVOLUTIONTI
Yes
Yes
Cystoscope (CYF Series)
CYF-5A
N3627870 CYF-5A CYSTOSCOPE E
Yes
Yes
Cystoscope (CYF Series)
CYF-5R
CYF-5R Flex CystoNephro Fiberscope Rever
Yes
Yes
Cystoscope (CYF Series)
CYF-V2
CYF-V2 VISERA Cysto-Nephro v
Yes
Yes
Cystoscope (CYF Series)
CYF-V2R
CYF-V2R Flex CystoNephro Videoscope Rev
Yes
Yes
Cystoscope (CYF Series)
CYF-VA2
CYF-VA2 VISERA Cysto-Nephro Videoscope
Yes
Yes
Cystoscope (CYF Series)
CYF-VH
CYF-VH HD Flex CystoNephro Videoscope
Yes
Yes
Cystoscope (CYF Series)
CYF-VHA
CYF-VHA HD FlexCystoNephroVideoscope
Yes
Yes
Cystoscope (CYF Series)
CYF-VHR
CYF-VHR HD FlexCystoNephroVideoscope
Yes
Yes
Ureterscope (URF Series)
URF-P5
N3627930 OLA URF-P5 URF-P5 FLEXIBLE URET
Yes
Yes
Ureterscope (URF Series)
URF-P6
URF-P6 SUPER-SLIM FLEXIBLE FIBEROPTIC UR
Yes
Yes
Ureterscope (URF Series)
URF-P6R
URF-P6R SUPER-SLIM FLEXIBLE FIBEROPTIC U
Yes
Yes
Ureterscope (URF Series)
URF-P7
URF-P7 Flex Uretero Fiberscope
Yes
Yes
Ureterscope (URF Series)
URF-P7R
URF-P7R Flex Uretero Fiberscope
Yes
Yes
Ureterscope (URF Series)
URF-V
URF-V EndoEYE Flexible Ureteoscope
Yes
Yes
Ureterscope (URF Series)
URF-V2
URF-V2 SLIM FLEXIBLE VIDEO URETEROSCOPE
Yes
Yes
Ureterscope (URF Series)
URF-V2R
URF-V2R SLIM FLEX VID URETERO SCOPE, REV
Yes
Yes
Ureterscope (URF Series)
URF-V3
URF-V3 URETEROSCOPE, FLEX, VIDEO, STD
Yes
Yes
Ureterscope (URF Series)
URF-V3R
URF-V3R URETEROSCOPE, FLEX, VIDEO, REV
Yes
Yes
Choledochoscope (CHF Series)
CHF-P20Q
CHF-P20Q CHOLEDOCHOINEPHRO CYS TOFIBERSCOPE
No
No
Choledochoscope (CHF Series)
CHF-CB30L
CHF-CB30L TRANSLAPAROSCOPIC CHOLEDOCHOSCOPE
No
No
Choledochoscope (CHF Series)
CHF-BP30
CHF-BP30 OES CHOLEDOCHOFIBER
No
No
Choledochoscope (CHF Series)
CHF-P60
CHF-P60 OES CHOLEDOCHOSCOPE
No
No
Hysteroscope (HYF Series)
HYF-1T
OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE 1T
No
No
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:
Luer-Split model MAJ-2092 + Seal-Port
Adjustable Biopsy Port Seal Y-Adapter model BPS-Y
A full listing of Olympus Endoscopes compatible with the MAJ-891 and Compatible Alternative Devices to MAJ-891 is shown above.
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.
Reason for 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.
Additional FDA Resources
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.
Content current as of:
03/05/2025
Regulated Product(s)