—#180371

Product

daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

FDA product code: GAG — Stapler, Surgical
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K173721
Affected lot / code info: Lot numbers: T10180511; T10180718; T10180821;T10180822; T10180906; T10180913; T10180925; T10181008; T10190204; T10190208; T10190213; T11180816; T11190219

Why it was recalled

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

Root cause (FDA determination)

Employee error

Action the firm took

On July 1, 2019 , the firm sent an "Urgent Medical Device Recall" notification to affected customers concer the da Vinci Xi SureForm 60 Stapler Reload. In addition to informing customer's about the recalled product, the firm asked customers to take the following actions: 1. Intuitive Surgical requests customers locate the affected Stapler Reloads at each site and return them. 2. Inform necessary personnel when corrective action has been completed. 3. If customer has distributed any affected product to other sites, please forward this notice to all related parties. 4. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 5. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form, or complete using the da Vinci online resource tool.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Switzerland, United Kingdom.

Timeline

Recall initiated: 2019-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.