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.

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 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418

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