—#139635

Product

Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K112208, K122532, K130726
Affected lot / code info: Model numbers: 428080-04, 428080-05; all lots

Why it was recalled

In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.

Root cause (FDA determination)

Device Design

Action the firm took

Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Ensure that 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 Surgery procedures. 2. Replace any instrument that shows signs of damage and contact Intuitive Surgical Customer Service. 3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual. If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.

Timeline

Recall initiated: 2015-08-08
Posted by FDA: 2015-09-10
Terminated: 2015-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139635. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.