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-0099-2018
Product summary
- Event
- Event 77662
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-0099-2018
Official wording
Reason: Observed instability of the device.
Code information: Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15058, RO15059, RO15061, RO15063, RO15064, and RO15069
Distribution pattern: Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX
Derived failure modes
-
Unknown
Observed instability of the device.