COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Recall Reason Description
Risk of device contamination that may result from improper reprocessing.
- Company Name:
- Olympus Corporation
- Brand Name:
- Product Description:
-
Product Description
MAJ-891 endoscope accessory
Company Announcement
CENTER VALLEY, Pa., (January 29, 2025) – 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.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch program online:
For information or to report a problem, please contact the Olympus Technical Assistance Center at 800-848-9024, Option 1 or email complaints@olympus.com.
Media Contacts
Stephanie Sherry, Vice President, Corporate Communications
484-896-5206, stephanie.sherry@olympus.com
Susan Scerbo, Senior Manager, Public Relations
484-505-0407, sue.scerbo@olympus.com
