Z-0653-2016Class II

30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery...

Name: Z-0653-2016 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery...
Creator: Intuitive Surgical, Inc.
Published: 2015-11-23
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-11-23 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition... on 2015-11-23. FDA classified it as Class II and gives the reason as "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 energy instruments...". 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-0653-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Posted: 2016-01-14
Terminated: 2016-04-05
Recalling firm: Intuitive Surgical, Inc.
Product: 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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 energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive Surgical sent an Urgent Medical Device Correction letter to affected customers on December 4, 2015,. Letters explained the issue and provided action to follow to prevent the issue. Customers were instructed to do the following: Distribute a copy of this letter to all da Vinci 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. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: [email protected] Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)
Quantity in commerce: 2624 total all models
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. .
Product codes and lots: Model numbers: 470027-34, 470027-40, 470027-41. All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0653-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0652-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-14
Z-0653-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-14

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

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)