Device 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.
Z-1252-2017
Product summary
- Event
- Event 75993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,627 units (769 URF-V2 and 858 URF-V2R)
- Official record key
device-enforcement:Z-1252-2017
Official wording
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 information: All serial numbers
Distribution pattern: Worldwide distribution-US Nationwide and country of: Canada.
Derived failure modes
-
Unknown
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.