Duodenoscope And Accessories, Flexible/rigid

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideo

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

CRE Wireguided 6-8mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Wireguided 8-10mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Wireguided 10-12mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Wireguided 15-18mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Wireguided 18-20mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

Brand Name: EVIS EXERA III Duodenovideoscope

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.

Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V-

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.

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

Poor image quality due to fluid ingress in the lens.