Recall Z-1251-2017— Olympus Corporation of the Americas

Name: FDA recall Z-1251-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-12

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2016-12-12, terminated 2018-02-26. It names one FDA 510(k) clearance: K912120. Product: URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Terminated: 2018-02-26
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K912120 — URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEOlympus Corp.·cleared 1991-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.