Device product
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.
Z-1819-2017
Product summary
- Event
- Event 76911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 x 6 packs (90 units)
- Official record key
device-enforcement:Z-1819-2017
Official wording
Reason: Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
Code information: All
Distribution pattern: US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
Derived failure modes
-
Device software or design
software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can