The Recall Desk
SevereFDA (Devices)·Z-1252-2017·Announced 2017-03-08

Olympus Uretero-reno Videoscope Recall Due to Insertion Tube Breakage

Olympus is recalling URF-V2 and URF-V2R endoscopes because the insertion tube bending section may break during surgery, causing tissue trauma.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a Class II medical device with reports of significant injury, including tissue trauma, perforation, and the need for surgical removal of broken parts.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,627 units of Uretero-reno videoscope URF-V2 and URF-V2R endoscopes and accessories. These devices are intended for endoscopic diagnosis and treatment within the ureter and kidney. The recall covers units distributed in the United States and Canada.

The recall was initiated after Olympus received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these incidents were associated with tissue trauma, including perforation. In some cases, the insertion tubes became stuck inside the patient and required surgical removal.

Healthcare providers should stop using these devices and contact Olympus for further instructions. Consumers who have had these devices used on them should consult their healthcare provider.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.