Intuitive Surgical, Inc.: da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460

Recall number

Z-0999-2022

Recalling firm

Intuitive Surgical, Inc.

Product

da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460

Status

Open, Classified

Initiated

2022-03-17

Posted

not on file

Terminated

not on file

Reason

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.

Root cause

Under Investigation by firm

Action

On 03/17/2022, the firm sent an "Urgent Medical Device Correction" letter via FedEx informing customers that there is a potential for injury associated with the stapler instruments if target tissue fails to remain in place with the jaws of the stapler during the stapler firing sequence. This phenomenon is referred to as a "tissue pushout event". As the staple firing sequence progresses, the target tissue is transected but the target tissue is not approximated due the lack of staple engagement with the tissue. This type of event may result in un-approximated tissue and occurs when attempting to cross over existing staple lines in the creation of a continuous staple line. Customer are being instructed to place the customer communication with the User Manual and in addition: 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the Surgical System that they should review and understand contents of this letter and reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the SureForm Instruments and Accessories User Manual Addendum b. Contacting their Sales Representatives for clarification of queries. 3. Complete the Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for their files. Customers are also informed that they can continue to use their instruments by following instructions: -Users are advised to use caution when unable to avoid crossing over existing staple lines and continue to adhere to all existing warnings and cautions found in the SureForm Instruments and Accessories User Manual Addendum. -If a tissue pushout event is occurring, users may limit unapproximated tissue by pressing the emergency stop button (on Surgeon Console or Patient Cart helm), after which the SureForm stapler can be safely unclamped from the tissue using the Manual Release Knob. For questions or fu

Quantity

6,8881 boxes (or 413,286 individual units/6 instruments/box)

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Lot, serial or model codes

Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots

510(k) numbers

["K173721","K183224","K190999"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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