Device product
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Z-1424-2013
Product summary
- Event
- Event 65094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,374
- Official record key
device-enforcement:Z-1424-2013
Official wording
Reason: Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Code information: Model number 552002-01
Distribution pattern: US Distribution Only
Derived failure modes
-
Unknown
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.