Skip to content
Recall Observatory FDA recall evidence

Device product

Uretero-reno fiberscope URF-P6

Z-2519-2018

January 17, 2018

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 79701
Status
Terminated
Classification
Class II
Quantity
1062
Official record key
device-enforcement:Z-2519-2018

Official wording

Reason: Breakage of the endoscope's insertion tube bending section during surgical procedures.

Code information: All serial numbers

Distribution pattern: US Nationwide. Canada and Mexico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Breakage of the endoscope's insertion tube bending section during surgical procedures.