Device product
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Z-0105-2018
Product summary
- Event
- Event 77742
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0105-2018
Official wording
Reason: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Code information: Serial No. BR16004, BR15002, and BR15003
Distribution pattern: Worldwide Distribution - US (DC) and Internationally to Australia and France.
Derived failure modes
-
Unknown
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.