Z-1568-2016Class II

EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software...

Name: Z-1568-2016 EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software...
Creator: Intuitive Surgical, Inc.
Published: 2016-03-25
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2016-03-25 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope... on 2016-03-25. FDA classified it as Class II and gives the reason as "Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1568-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Posted: 2016-04-26
Terminated: 2016-07-01
Recalling firm: Intuitive Surgical, Inc.
Product: EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: 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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
Root cause tag: software
FDA root cause: Software design
Action: Intuitive Surgical sent an Urgent Product Safety notification to customers via e-mail on March 25, 2016. Customers were advised to STOP USE on the EndoWrist Stapler 45 and 30 instruments on da Vinci XI systems with p5 software. Product letters followed and were mailed on March 31, 2016 by Fed Ex. Urgent Medical Device letters were sent via Fed Ex on March 31, 2016 (dated April 1, 2016). These letters reiterated what was explained in the previous e-mail and provide more information of the unexpected motion issue. In addition to the stop use request, letters requested that all personnel be fully informed of the issue. Further information or support concerning this issue, please contact your Clinical Sales Representative or contact ISI Customer Service at the number: North America: 800-876-1310 Option 3 (6 am to 5pm PST)
Quantity in commerce: 43
Distribution: US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.
Product codes and lots: da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101 SK0326 SK0654 SK0106 SK0358 SK0665 SK0119 SK0360 SK0701 SK0143 SK0382 SK0702 SK0144 SK0408 SK0710 SK0146 SK0438 SK0722 SK0171 SK0456 SK0728 SK0173 SK0484 SK0181 SK0492 SK0216 SK0496 SK0230 SK0516 SK0233 SK0548 SK0237 SK0552 SK0238 SK0610 SK0263 SK0612 SK0286 SK0631 SK0291 SK0649.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1568-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1568-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-26

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)