Recall Z-0845-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
The da Vinci SP surgical system 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 SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
| Date | Oct 23, 2018 |
| Status | Terminated |
| Reason | The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/23/2018, the firm sent a "Medical Device Correction" Letter informing them about the cannula mount button issue and informing all personnel who are involved with da Vinci SP Surgery at their site of the following instructions. 1. Release the cannula mount button in a slow and controlled manner. This will prevent the button from snapping back potentially causing button damage. 2. If button damage occurs prior to procedure, discontinue use of the affected SP system. 3. If button damage occurs during a procedure, call dVSTAT for instructions to complete the procedure. ------------ 4. Comple |
| Quantity | 5 PSCs (Units) |
| Distribution | Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc., May 31, 2018 |