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Recall Observatory FDA recall evidence

Device product

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Z-0379-2022

November 02, 2021

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 88981
Status
Ongoing
Classification
Class II
Quantity
14,447 units
Official record key
device-enforcement:Z-0379-2022

Official wording

Reason: Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

Code information: All serial numbers. UDI: 04953170339967

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.