Olympus Corporation of the Americas — Class II: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duoden
Olympus has initiated a Class II recall to replace the previous design of the Single Use Distal Cover (Model MAJ-2315) with a newly designed version for use with the EVIS EXERA III Duodenovideoscope TJF-Q190V.
Olympus Corporation of the Americas and healthcare facilities utilizing the EVIS EXERA III Duodenovideoscope TJF-Q190V and associated single-use distal covers.
The replacement of a distal cover design suggests a proactive measure to address potential performance or safety issues associated with the previous iteration. This update likely impacts reprocessing protocols or distal end protection, requiring clinical and facilities teams to ensure older stock is phased out in favor of the redesigned component.
Facilities using the TJF-Q190V should verify inventory against catalog number MAJ-2315 and transition to the newly designed version as indicated by the manufacturer. Regulatory teams should document the replacement process within their post-market surveillance or CAPA systems.
Class II. Reason: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.. Product: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid. Firm: Olympus Corporation of the Americas (Center Valley PA United States). Status: Ongoing.
Open in openFDA / FDA.gov