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SureForm recallZ-0999-2022 · Intuitive Surgical, Inc. · initiated Mar 17, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 Intuitive s existing risk documentation.

FDA root cause category: Under Investigation by firm

What the company is doing

On 03/17/2022, the firm sent an Urgent Medical Device Correction letter informing customers of 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 to 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. Place this letter with the User Manual. Notify all surgeons and personnel using the Surgical System to review and understand contents of this letter and reacquaint themselves by reading the instructions, warnings, and cautions in the SureForm Instruments and Accessories User Manual Addendum. Customers can continue to use their instruments by following instructions: 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 further assistance, contact Clinical Sales Representative or Customer Service at: -US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4AM to 5PM PST) or mail: [email protected] -Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +4121 821 2020 (8AM to 6PM CET) or [email protected] -South Korea: 02-3271-3200 (9AM to 6PM KSTJ) or [email protected]

Recall details

Recall number
Z-0999-2022
Status
Open, Classified
Initiated by the company
Mar 17, 2022
Posted by the FDA
Apr 22, 2022
Recalling firm
Intuitive Surgical, Inc.
Quantity
6,8881 boxes (or 413,286 individual units/6 instruments/box)
Product code
NAY
FDA submissions
K183224, K190999, K173721
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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