Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1251-2017 — URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

U.S. FDA — Device Enforcement · United States · 2016-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1251-2017
Date of alert
2016-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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