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U.S. Department of Health and Human Services

Class 2 Device Recall Ureteroreno videoscope URFV2 and URFV2R

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  Class 2 Device Recall Ureteroreno videoscope URFV2 and URFV2R see related information
Date Initiated by Firm December 12, 2016
Create Date February 24, 2017
Recall Status1 Terminated 3 on February 27, 2018
Recall Number Z-1252-2017
Recall Event ID 75993
510(K)Number K072957  
Product Classification Endoscope, accessories, narrow band spectrum - Product Code NWB
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.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Olympus, sent an "Urgent Medical Device Safety Notice" on December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus were taking 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 and complete and return the OLYMPUS URGENT MEDICAL DEVICE SAFETY NOTIFICATION via fax to: Olympus Regulatory Affairs Department at 484-896-7128.
Quantity in Commerce 1,627 units (769 URF-V2 and 858 URF-V2R)
Distribution Worldwide distribution-US Nationwide and country of: Canada.
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 = NWB and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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