Single Use Distal Cover 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
Published February 21, 2024 · Recall initiated: December 8, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- UDI: 04953170441271 All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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