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Recall Observatory FDA recall evidence

Device product

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

Z-1613-2023

April 18, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92115
Status
Ongoing
Classification
Class II
Quantity
309278 pieces
Official record key
device-enforcement:Z-1613-2023

Official wording

Reason: The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

Code information: UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.