Z-1431-2013Class II

8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use...

Name: Z-1431-2013 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use...
Creator: Intuitive Surgical, Inc.
Published: 2013-05-08
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2013-05-08 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments on 2013-05-08. FDA classified it as Class II and gives the reason as "Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar 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-1431-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-08
Posted: 2013-05-29
Terminated: 2014-02-18
Recalling firm: Intuitive Surgical, Inc.
Product: 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated May 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice.
Quantity in commerce: 697 units - all products
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
Product codes and lots: Model number: 400110-10; Lot numbers: M10120807 M10120817 M10120831 M10120910 M10121008 M10121012 M10121024 M10121115 M10121123 M10121130 M10121206 M10121210 M10130124 M10130131 M10130205 M10130304 M10130319 M10130321

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1431-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29
Z-1432-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29
Z-1433-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29

Product code NAY

K012833Class IIIntuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. / cleared 2001-11-16

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)