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Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes...

FDA Recall #Z-1252-2017 — Class II — December 12, 2016

Recall #Z-1252-2017 Date: December 12, 2016 Classification: Class II Status: Terminated

Product Description

Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.

Reason for Recall

Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1,627 units (769 URF-V2 and 858 URF-V2R)

Distribution

Worldwide distribution-US Nationwide and country of: Canada.

Code Information

All serial numbers

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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