# K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 28, 2014 after 277 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 80 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K930667 (1994). 54 ancestors in all.
124 later devices descend from it; 32 cite it directly.
1 of 179 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000, Intuitive Surgical, Inc. (2009) Summary page 1.
- K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals, Intuitive Surgical, Inc. (2012) Summary page 1.

## Cited in the summary but kept off the family tree
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), 70 descendants of its own
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (2016), 68 descendants of its own
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), 44 descendants of its own
- K182160: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM (2018), 33 descendants of its own

## Recalls of this device
- Apr 2, 2026 · Class II · Z-2046-2026: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Nov 7, 2025 · Class II · Z-1232-2026: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Mani
- Dec 19, 2024 · Class II · Z-0872-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0862-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0866-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0855-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0867-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0856-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0881-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0923-2025: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Dec 19, 2024 · Class II · Z-0924-2025: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Dec 19, 2024 · Class II · Z-0869-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0874-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0878-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0861-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0868-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0880-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0876-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0847-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0849-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0875-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0865-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0851-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0854-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0857-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0848-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0859-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0860-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Dec 19, 2024 · Class II · Z-0863-2025: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Jun 12, 2023 · Class II · Z-2059-2023: Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be
- Feb 10, 2023 · Class II · Z-1293-2023: Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
- Jan 24, 2023 · Class II · Z-1262-2023: Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowin
- Sep 20, 2022 · Class II · Z-0133-2023: Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected t
- Jul 1, 2022 · Class II · Z-1460-2022: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
- Sep 21, 2021 · Class II · Z-0275-2022: Incorrect expiration date on its package labeling (shipper box and inner carton label).
- Jul 26, 2019 · Class II · Z-0925-2020: The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, yo
- Jun 17, 2019 · Class II · Z-0283-2021: One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperatur
- Apr 11, 2019 · Class II · Z-1896-2020: 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.
- Dec 4, 2018 · Class II · Z-1105-2020: This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar ene
- Nov 21, 2018 · Class II · Z-1960-2020: Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
- Aug 15, 2018 · Class II · Z-3025-2018: 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,
- Jul 16, 2018 · Class II · Z-3254-2018: Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
- May 17, 2018 · Class II · Z-2835-2018: An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbala
- Jun 1, 2017 · Class II · Z-2630-2017: da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
- Oct 5, 2016 · Class II · Z-0315-2017: Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
- Mar 25, 2016 · Class II · Z-1568-2016: Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to t
- Mar 16, 2016 · Class II · Z-1377-2016: 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 
- Feb 16, 2016 · Class II · Z-1191-2016: 
- Nov 23, 2015 · Class II · Z-0653-2016: This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar 
- Nov 23, 2015 · Class II · Z-0652-2016: This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar 

## Indications for use
The Intuitive Surgical Endloscopic Instrument Control System (da Vinci Surgical System, Model lS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scissors, scalpels, forcepsipick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotorny procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularination. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians 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/K131861
Methodology: https://510kreport.com/methodology