—#192324

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

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K173721, K183224, K190999
Affected lot / code info: Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots

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 Intuitives existing risk documentation.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.