Recall Z-1896-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical Inc
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM)
| Date | Apr 11, 2019 |
| Status | Terminated |
| Reason | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking. |
| Root cause | Process control |
| Action | On 04/11/2019, the firm sent an "Urgent Medical Device Correction" notifications via FedEx to its customers informing them that the Recalling Firm has become aware that specific Surgical Systems arms have the potential to encounter friction in specific instrument arm orientations. As a result, sluggish, jerky, or hesitating motion may be experienced at the instrument tip and/or resistance felt in the hand controls. To correct this issue, a Recalling Firm's representative will schedule a site visit to perform evaluations on their systems. Based on the results of the evaluation, any necessary |
| Quantity | 270 USM units on a combination of 100 unique systems |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |