Duodenoscope And Accessories, Flexible/Rigid
FDA adverse event reports and recall history for duodenoscope and accessories, flexible/rigid (product code FDT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 23,218
- Deaths
- 184
- Injuries
- 2,630
- Malfunctions
- 20,340
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-07Open, ClassifiedDevice Design
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
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2025-11-21Open, ClassifiedDevice Design
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
- 2024-02-09Open, ClassifiedDevice Design
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
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.
- 2023-11-21Open, ClassifiedProcess control
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Poor image quality due to fluid ingress in the lens.
Monitor duodenoscope and accessories, flexible/rigid automatically
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