Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 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, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.

A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.

The firm, Intuitive Surgical, sent an " Urgent Medical Device Correction" letter dated October 2, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure all affected personnel are fully informed of this notice; after receiving the updated manual, locate and discard all previous versions of the Single Site Instruments manual and replace with the new manual; complete and return the attached Acknowledgement Form via FAX to Intuitive Surgical, Inc., ATTN: REGULATORY COMPLIANCE, U.S. (408) 716-3040, or Scan and Email to: [email protected].; Inform affected personnel when the correction has been completed; and Retain a copy of this Notice and the Acknowledgement Form for your files. If you have any questions, 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) " Japan: 0120-56-5635 or 003-5575-1362 (9 am to 6 pm JST) " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET).