—#148513

Product

STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K140553
Affected lot / code info: All model 470430

Why it was recalled

Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Intuitive sent a Stop Use e-mail to all affected sites on July 14, 2016 to inform users of the issue prior to the commencement of a recall. E-mail described the problem and asked that all surgeons who use the stapler be informed to immediately stop use. Formal letters will follow. Medical Device Recall letters were sent on July 21, 2016. Customers were instructed to return quarantined affected product whether used or unused to Intuitive Surgical. Customers should contact customer service to initiate the standard Return Material Authorization (RMA) process by phone or email: North and South America: 800-876-1310, option 3 (6AM to 5PM PST) Email: customersupport..servicesupport@intusurg.com Europe, Middle East, Asia and Africa Phone: 800-821-2020 or +41 21 821 2020 Email: ics@intusurg.com Customers were also instructed to complete the attached Return Acknowledgement Form and submit via email to Regulatory Compliance at isi.compliance@intusurg.com or by fax to +1 (408) 523-0619. For questions regarding this recall call 408-523-2100. 10-31-16 Update: Monthly status update states that an additional 93 instruments have been identified and an additional communication will be sent to these sites in Mid November 2016,

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,

Timeline

Recall initiated: 2016-07-14
Posted by FDA: 2016-08-26
Terminated: 2017-01-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.