Device product
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Z-0100-2018
Product summary
- Event
- Event 77667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-0100-2018
Official wording
Reason: Potential failure of the optical distance sensor due to cable disconnection.
Code information: Serial No. RO10011 and RO10014
Distribution pattern: Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
Derived failure modes
-
Unknown
Potential failure of the optical distance sensor due to cable disconnection.