—#53388

Product

Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, Inc., Sunnyvale, CA

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K061260
Affected lot / code info: All instruments manufactured till 03/21/07

Why it was recalled

Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)

Root cause (FDA determination)

Device Design

Action the firm took

On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 950 Kifer Rd, Sunnyvale, California 94086-5206

Distribution

Distribution pattern: Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)

Timeline

Recall initiated: 2007-04-13
Posted by FDA: 2008-01-24
Terminated: 2008-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.