Device product
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Z-1109-2013
Product summary
- Event
- Event 64755
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1642 customers
- Official record key
device-enforcement:Z-1109-2013
Official wording
Reason: Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Code information: Model number 550516-05
Distribution pattern: Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.