Z-1142-2015Class II

EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi...

Name: Z-1142-2015 EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi...
Creator: Intuitive Surgical, Inc.
Published: 2015-02-11
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-02-11 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar... on 2015-02-11. FDA classified it as Class II and gives the reason as "Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws". 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-1142-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-11
Posted: 2015-02-24
Terminated: 2015-06-01
Recalling firm: Intuitive Surgical, Inc.
Product: EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Intuitive Surgical sent an Urgent Medical Device Correction letter dated Feruary 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Forward this letter to any members of your medical staff who perform da Vinci procedures in addition to your Risk Manager, OR Director, Purchasing and Biomedical Engineering staff. 2. This field correction does not require you to quarantine or return the affected devices. Vessel Sealers can continue to be used safely by adhering to the following guidelines as provided in the Vessel Sealer User Manual: a. Only procedures that incorporate sealing and transection of thin tissue bundles and small diameter vessels are affected by this issue. Prior to the procedure, determine whether this issue may be a factor and choose whether or not to use the device per the following instructions. Alternative methods of sealing and transection are described below. b. During sealing, always inspect tissue for energy effect (i.e. blanching, steam, bubbling) along the entire jaw of the instrument. While audio tones designate seal cycle completion, tissue effect should always be seen prior to proceeding to cut. If no tissue effect is seen, then DO NOT CUT. Re-grasp tissue and re-attempt sealing as described above. If the issue persists, the instrument may be affected and an alternative means of sealing and transecting thin vascular tissue bundles should be used. These other methods include using another da Vinci Vessel Sealer, alternative da Vinci electrosurgical instruments, a da Vinci Harmonic instrument or hand-held laparoscopic sealing device. 3. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 4. Please retain a copy of this letter and the Acknowledgement Form for your files. 5. If you choose to not continue to use affected Vessel Sealer instruments, you may retu
Quantity in commerce: 3282 - total both part numbers
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Product codes and lots: PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1142-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1141-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-24
Z-1142-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-24

Product code NAY

K140189Class IIEndowrist Vessel SealerIntuitive Surgical, Inc. / cleared 2014-06-05

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)