—#130164

Product

EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K123463
Affected lot / code info: EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.

Why it was recalled

Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

Root cause (FDA determination)

Device Design

Action the firm took

Intuitive Surgical sent an Urgent Product Notice letter dated September 19, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Immediately stop using the EndoWrist Stapler 45 instrument. -Quarantine the EndoWrist Stapler 45 instruments within your hospital. Keep the instruments quarantined until Intuitive Surgical sends you a subsequent communication with instructions regarding the quarantined product. -Ensure all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, and members of your medical staff who perform da Vinci Si surgery procedures using the EndoWrist Stapler 45 instrument. -Please retain a copy of this notice for your records with your da Vinci Si User Manual. If you need further information or support concerning this Product Notice, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at 800-876-1310 Option 3 (6 am to 5 pm PST).

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2014-09-18
Posted by FDA: 2014-10-16
Terminated: 2015-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.