URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

FDA Recall #Z-1251-2017 — Class II — December 12, 2016

Recall #Z-1251-2017 Date: December 12, 2016 Classification: Class II Status: Terminated

Product Description

Reason for Recall

Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.

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

3461 units distributed to US consignees

Distribution

Distributed Nationwide

Code Information

All serial numbers are affected.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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