Z-0659-2008

da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale...

Name: Z-0659-2008 da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale...
Creator: Intuitive Surgical, Inc.
Published: 2007-03-09
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2007-03-09 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086 on 2007-03-09. The reason FDA records is "Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0659-2008
Status: Terminated
Initiated: 2007-03-09
Posted: 2008-01-31
Terminated: 2011-04-19
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions.
Quantity in commerce: 11 units
Distribution: Worldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden.
Product codes and lots: Part #42011-01, Lot # :SA061101

Product code NAY

K050369Class IIIntuitive Surgical Da Vinci Surgical System, Model Is2000Intuitive Surgical, Inc. / cleared 2005-04-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)