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.
Recall
- Recall Number
- Z-1252-2017
- Event Number
- 75993
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- NWB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 12, 2016
- Terminated
- February 27, 2018
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610
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.
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.
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.
Worldwide distribution-US Nationwide and country of: Canada.
1,627 units (769 URF-V2 and 858 URF-V2R)