Recall Z-1252-2017— Olympus Corporation of the Americas

Name: FDA recall Z-1252-2017
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 2018-02-27. It names one FDA 510(k) clearance: K072957. Product: 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: 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
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Terminated: 2018-02-27
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072957 — EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation·cleared 2008-03-18

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

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.

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