Recall Z-1252-2017 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Olympus Corporation of the Americas
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.
| Date | Dec 12, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1,627 units (769 URF-V2 and 858 URF-V2R) |
| Distribution | Worldwide distribution-US Nationwide and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072957 | EVIS EXERA II 180 SYSTEM Olympus Medical Systems Corporation, Mar 18, 2008 |