Urf-P2 Ureterorenofiberscope/Choledochofiberscope

• • Ongoing Z-0905-2025 FDA Class I ·initiated 18 Dec 2024

  Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

• • Terminated Z-1251-2017 FDA Class II ·initiated 12 Dec 2016

  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.

510(k) Number

K912120 ↗

FDA Product Code

FBN

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Olympus Infant Resectoscope and Accessories

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See all devices from Olympus Corp. →