Device product
Olympus Uretero-reno videoscope, Model No. URF-V2
Z-1116-2022
Product summary
- Event
- Event 90063
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1116-2022
Official wording
Reason: The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
Code information: 1 unit, serial number 2825505F UDI 04953170343582
Distribution pattern: US Nationwide distribution in the state of AZ.
Derived failure modes
-
Unknown
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.