Device product
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Z-1428-2013
Product summary
- Event
- Event 65083
- Status
- Terminated
- Classification
- Class II
- Quantity
- NA
- Official record key
device-enforcement:Z-1428-2013
Official wording
Reason: Clarification of existing labeling information and operating procedures.
Code information: Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping.
Distribution pattern: Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Derived failure modes
-
Unknown
Clarification of existing labeling information and operating procedures.