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Recall Observatory FDA recall evidence

Device product

Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R

Z-2518-2018

January 17, 2018

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 79622
Status
Terminated
Classification
Class II
Quantity
2548
Official record key
device-enforcement:Z-2518-2018

Official wording

Reason: Potential breakage of the endoscope s insertion tube bending section during surgical procedures

Code information: All Serial Numbers

Distribution pattern: US Nationwide and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential breakage of the endoscope s insertion tube bending section during surgical procedures