# K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 29, 2005 after 74 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 51 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930667 (1994). 27 ancestors in all.
230 later devices descend from it; 20 cite it directly.
1 of 258 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System, Intuitive Surgical, Inc. (2001)
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000, Intuitive Surgical, Inc. (2001)
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family, Intuitive Surgical, Inc. (2002) Summary page 1.
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000, Intuitive Surgical, Inc. (2002) Summary page 1.
- K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200, Intuitive Surgical, Inc. (2002) Summary page 1.
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments, Intuitive Surgical, Inc. (2004) Summary page 1.
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000, Intuitive Surgical, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180, Intuitive Surgical, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 228 descendants of its own
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000 (2006), 224 descendants of its own
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), 211 descendants of its own
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182 (2006), 155 descendants of its own
- K061260: Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 (2006), 154 descendants of its own

## Recalls of this device
- Dec 9, 2025 · Class II · Z-1701-2026: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Dec 9, 2025 · Class II · Z-1699-2026: Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Dec 9, 2025 · Class II · Z-1697-2026: Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Dec 9, 2025 · Class II · Z-1696-2026: Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Dec 9, 2025 · Class II · Z-1700-2026: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Dec 9, 2025 · Class II · Z-1698-2026: Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Jul 1, 2022 · Class II · Z-1459-2022: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
- Aug 15, 2018 · Class II · Z-3024-2018: Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft,
- Mar 16, 2016 · Class II · Z-1376-2016: Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result 
- May 21, 2015 · Class II · Z-1812-2015: The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
- Jun 13, 2014 · Class II · Z-2020-2014: Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
- May 21, 2014 · Class II · Z-1966-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1967-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1970-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1972-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1971-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1974-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1964-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1968-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1975-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1969-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1973-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1965-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- Nov 15, 2013 · Class II · Z-0521-2014: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
- Nov 15, 2013 · Class II · Z-0520-2014: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
- Nov 11, 2013 · Class II · Z-0436-2014: Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument
- May 6, 2013 · Class II · Z-1463-2013: Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
- Mar 15, 2013 · Class II · Z-1109-2013: Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
- Jul 13, 2012 · Class II · Z-2104-2012: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
- Jul 13, 2012 · Class II · Z-2103-2012: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
- Jul 13, 2012 · Class II · Z-2105-2012: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
- Jul 13, 2012 · Class II · Z-2102-2012: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
- Jul 13, 2012 · Class II · Z-2106-2012: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
- Jul 13, 2012 · Class II · Z-2101-2012: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
- Apr 27, 2012 · Class II · Z-1994-2014: Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
- Sep 19, 2011 · Class II · Z-1428-2013: Clarification of existing labeling information and operating procedures.
- Sep 19, 2011 · Class II · Z-1427-2013: Clarification of existing labeling information and operating procedures.
- Sep 19, 2011 · Class II · Z-1429-2013: Clarification of existing labeling information and operating procedures.
- Jul 15, 2009 · Not classified · Z-1161-2010: Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.
- Jun 1, 2008 · Not classified · Z-2204-2008: Defective software chip may cause the system to fail and lock up.
- Dec 27, 2007 · Not classified · Z-1180-2008: Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.
- Nov 19, 2007 · Not classified · Z-0669-2008: Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during 
- Oct 4, 2007 · Not classified · Z-0151-2008: Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. 
- Oct 4, 2007 · Not classified · Z-0152-2008: Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation
- May 14, 2007 · Not classified · Z-1245-2007: Product may malfunction and fail to start up on AC power.
- Mar 30, 2007 · Not classified · Z-0079-2008: System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.
- Mar 9, 2007 · Not classified · Z-0657-2008: Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
- Mar 9, 2007 · Not classified · Z-0658-2008: Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
- Mar 9, 2007 · Not classified · Z-0659-2008: Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
- Apr 12, 2006 · Not classified · Z-0670-2007: Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alte

## Indications for use
The Intuitive Surgical™ da Vinei® Surgical System is intended to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments including rigid endoscopes, bluni and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears. forceps/pick-ups, needle holders. endoscopic retractors, stabilizers, clectrocautcry and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection. approximation, ligation, clectrocautcry, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac rcvascularization. It is intended for usC by trained physiciaas in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.

Source page: https://510kreport.com/device/K050369
Methodology: https://510kreport.com/methodology