Model note · Surgical Robot
Intuitive da Vinci 5 Surgical System
The da Vinci 5 (IS5000) is an Intuitive surgical robot, cleared on 14 March 2024 (K232610) for adult urologic, general, gynaecologic and thoracoscopic laparoscopic surgery. It keeps the three part layout of surgeon console, patient side cart and vision tower, and uses Xi instruments. It adds force feedback instruments that pass forces at the tip back to the surgeon's hands, a CO2 insufflator with smoke evacuation built into the tower, and the E-200 electrosurgical generator. Its first field actions are useful for engineers: outdated viewer firmware that can drop 3D or all vision while instruments stay active, foot pedal springs that stick down, console column motor connectors (Error 23062), and a software error that let Xi family arms that failed a ball screw diagnostic stay in use.
The model
Maker, model and type.
- Maker
- Intuitive Surgical, Inc.
- Model
- da Vinci 5 Surgical System (IS5000) with integrated insufflator and E-200 generator
- Device type
- Surgical Robot
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | Computer controlled surgical system, product code NAY (with HIF for the insufflator), 21 CFR 876.1500; K232610 (14 March 2024), K241284 (3 July 2024) | Source |
| Indications | Control of Intuitive endoscopic instruments during urologic, general laparoscopic, gynaecologic laparoscopic and general thoracoscopic procedures in adults, by trained physicians in an operating room | Source |
| System parts | Surgeon Side Console, Patient Side Cart (robot), Vision System Cart (tower), endoscope, EndoWrist instruments and accessories; IS4000 (Xi) instruments are compatible | Source |
| Force feedback instruments | Large Needle Driver, MegaSutureCut Needle Driver, Cadiere Graspers, Fenestrated Bipolar Forceps and Maryland Bipolar Forceps with a sensor that sends tip forces to the hand controls | Source |
| Insufflator | Pneumatic CO2 insufflator in the tower, fed by house or tank CO2 through the tower manifold, with smoke evacuation; controlled from tower, console or robot touchscreens | Source |
| Endoscope and tray | da Vinci 5 endoscope about 600 mm long with an 8.8 mm shaft; stainless steel tray holds one endoscope, tray plus scope up to 13 lb | Source |
Recalls
Known FDA recalls.
- Z-2310-20262026-04-24
Near infrared handheld camera could stay on when illumination was turned off (1,357 systems).
FDA record - Z-1355-20262025-12-30
Viewer display with outdated firmware could lose 3D or all vision (47 consoles).
FDA record - Z-1428-20262025-11-17
Software release could lose user interface content on the external or tower monitor.
FDA record - Z-1232-20262025-11-07
Software let arms that failed the ball screw diagnostic stay in clinical use (X, Xi and da Vinci 5; 219 units).
FDA record - Z-1325-20252025-02-26
Foot tray pedal spring failures leave the pedal pressed (439 units).
FDA record - Z-0964-20262024-08-21
Console column motor connector failures, Error 23062 (144 units).
FDA record
Safety
Safety warnings from the record.
- Force feedback needle drivers are contraindicated in hysterectomy and myomectomy because of vaginal bleeding needing readmission or more procedures; use non force feedback drivers for suturing there. Source
- Losing vision while instruments stay active can lead to tissue contact, injury or bleeding and may need conversion to another surgical approach. Source
- A software release error could blank the user interface on the external or tower monitor (2025). Source
Sources
Where this note comes from.
- FDA 510(k) K232610 summary, da Vinci Surgical System IS5000 and da Vinci Insufflator
- openFDA 510(k) records for Intuitive Surgical
- openFDA device recall records for da Vinci 5
Not covered: The user and service manuals were not read, so power, network, insufflation pressure and flow ranges, and the full error code list are not included. The E-200 generator has its own clearance (K241635) not read here.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Surgical Robot