Class 2 Device Recall URFP6 Ureteroreno fiberscope and URFP6R Ureteroreno fiberscope

• Date Initiated by Firm: December 12, 2016
• Create Date: February 24, 2017
• Recall Status: Terminated on February 26, 2018
• Recall Number: Z-1251-2017
• Recall Event ID: 75990
• 510(K)Number: K912120
• Product Classification: Choledochoscope and accessories, flexible/rigid - Product Code FBN
• Product: URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
• Code Information: All serial numbers are affected.
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; PO Box 610; Center Valley PA 18034-0610
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.
• Quantity in Commerce: 3461 units distributed to US consignees
• Distribution: Distributed Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FBN