Single Site Curved Needed Driver 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.

Reason: 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.

Code information: Model number 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130521 S10130405 S10130401 S10130405 S10130405 S10130521 S10130405 S10130405 S10130406 S10130406 S10130411 S10130411 S10130613 S10130405 S10130327 S10130327 S10130319 S10130319 S10130626 S10130703 S10130405 S10130319 S10130521 S10130613 S10130502 S10130405 S10130401 S10130406 S10130521 S10130613 S10130502 S10130406 S10130411 S10130405 S10130327 S10130412 S10130613 S10130314 S10130411 S10130327 S10130327 S10130411 S10130406 S10130613 S10130626 S10130412 S10130521 S10130405 S10130405 S10130314 S10130401 S10130411 S10130626 S10130703 S10130703 S10130703 S10130626 S10130613 S10130502 S10130401 S10130412 S10130406 Batch/Lot # S10130412 S10130405 S10130412 S10130314 S10130319 S10130502 S10130613 S10130405 S10130314 S10130405 S10130405 S10130613 S10130709 S10130703 S10130314 S10130319 S10130319 S10130314 S10130412 S10130521 S10130626 S10130411 S10130405 S10130521 S10130405 S10130319 S10130319 S10130319 S10130405 S10130405 S10130405 S10130314 S10130314 S10130314 S10130314 S10130319 S10130319 S10130319 S10130319 S10130314 S10130314 S10130314 S10130405 S10130327 S10130327 S10130405 S10130405 S10130412 S10130405 S10130327 S10130406 S10130406 S10130406 S10130613 S10130502 S10130613 S10130502 S10130521 S10130502 S10130613 S10130411 S10130502 Batch/Lot # S10130412 S10130521 S10130521 S10130521 S10130521 S10130613 S10130521 S10130405 S10130401 S10130405 S10130405 S10130613 S10130613 S10130703 S10130703 S10130319 S10130319 S10130626 S10130703 S10130405 S10130405 S10130405 S10130405 S10130521 S10130521 S10130405 S10130327 S10130406 S10130412 S10130412 S10130411 S10130401 S10130405 S10130521 S10130502 S10130406 S10130613 S10130411 S10130613 S10130613 S10130405 S10130401 S10130327 S10130405 S10130406 S10130405 S10130405 S10130405 S10130319 S10130319 S10130406 S10130406 S10130703 S10130613 S10130502 S10130412 S10130412 S10130406 S10130406 S10130521 S10130626 S10130405 S10130401 S10130412 S10130405 S10130405 S10130613 S10130502

Distribution pattern: Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. .