FDA Enforcement
Class II
Terminated
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: Z-1252-2017
·
Reported March 8, 2017
Enforcement
- Recall Number
- Z-1252-2017
- Event ID
- 75993
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 8, 2017
- Initiation Date
- December 12, 2016
- Classification Date
- February 24, 2017
- Termination Date
- February 27, 2018
- Address
- 3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States
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
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.
Code Info
All serial numbers
Distribution
Worldwide distribution-US Nationwide and country of: Canada.
Quantity
1,627 units (769 URF-V2 and 858 URF-V2R)