Intuitive Surgical, Inc.

FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.

General and Plastic Surgery Devices

1

No

The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.

Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01

The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected:  0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.

General and Plastic Surgery Devices

2

No

Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.

8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, || Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

System Numbers:  SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.

General and Plastic Surgery Devices

2

No

Nationwide.

Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

All instruments manufactured till 03/21/07

General and Plastic Surgery Devices

2

No

Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)

Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, Inc., Sunnyvale, CA

Model number IS2000, part number 351040-04. System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174, SG175, SG184

General and Plastic Surgery Devices

2

No

Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.

daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.