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.
Reported: March 8, 2017 Initiated: December 12, 2016 #Z-1252-2017
Product 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 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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1,627 units (769 URF-V2 and 858 URF-V2R)
- Distribution
- Worldwide distribution-US Nationwide and country of: Canada.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Olympus Corporation of the Americas. Units affected: 1,627 units (769 URF-V2 and 858 URF-V2R).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1252-2017.
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