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Recall Observatory FDA recall evidence

Device product

Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Z-1010-2019

December 17, 2018

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 82099
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1010-2019

Official wording

Reason: The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.

Code information: Serial Number 2506043 and 2619818

Distribution pattern: US Nationwide distribution in the states of CT, IL, MN, MO, and NC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.