Z-1377-2016Class II

da Vinci S Surgical System (IS4000) user manual English and OUS

Name: Z-1377-2016 da Vinci S Surgical System (IS4000) user manual English and OUS
Creator: Intuitive Surgical, Inc.
Published: 2016-03-16
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2016-03-16 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical... on 2016-03-16. FDA classified it as Class II and gives the reason as "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 in an increase of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1377-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-16
Posted: 2016-04-12
Terminated: 2016-07-01
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware 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 cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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 in an increase of microscopic metallic particulates generated from the contact with the probes.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive sent a Field Safety Notice/Urgent Medical Device Correction letters dated March 22, 2016 by trackable mail method to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. In addition to existing instructions for use, observe the following warning when manipulating the cardiac ablation probe, Use only the Cardiac Probe Grasper to manipulate a cardiac ablation probe. 2. Distribute a copy of this letter to all da Vinci S, Si, and Xi users at your facility. 3. Place a copy of this letter with your user manual. 4. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 5. Retain a copy of this letter and the Acknowledgement Form for your files. Intuitive Surgical will provide a user manual addendum to incorporate the warning related to this risk. For questions contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service.
Quantity in commerce: 248 - total all models
Distribution: Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: Model number 551457- IS4000 English: Model number 551706 - IS4000 OUS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1377-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12
Z-1377-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)