Recall Z-1819-2017 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
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 fo
| Date | Apr 13, 2017 (initiated Mar 31, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Firm sent e-mails on 3-17-17 to affected sites instructing them to STOP USE of the XI Suction Irrigator and RMA. and return all unused Xi Suction/irrigation instruments for credit. A formal letters was sent to affected sites on March 31, 2017. Letters advised of the reason for recall with details on product name and product number. Letters requested that any unused devices be returned to Intuitive via the standard RMA process. All personnel who use the Da Vinci system should be made aware of the issue. Response form should be completed online or by returning copy enclosed with the letter. |
| Quantity | 15 x 6 packs (90 units) |
| Distribution | US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162973 | EndoWrist Suction Irrigator Intuitive Surgical, Inc., Feb 6, 2017 |