Device product
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Z-1048-2015
Product summary
- Event
- Event 70181
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,034
- Official record key
device-enforcement:Z-1048-2015
Official wording
Reason: The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.
Code information: PN 410298-05, -06, -07, -08, -09
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.