Device Recall da Vinci Xi Surgical System

Material number: 3680662-20: Serial numbers: 1311140273, 1311140370, 1311140385, 1311140148, 1311140099, 1311140152, 1311140081, 1311140473, 1311140561, 1311140409.  Material number: 380662-21: Serial numbers: 1311140225, 1311140437, 1311140476, 1311140336,  1311140472, 1311140438, 1311140353, 1311140195, 1311140545, 1311140098 1311140189, 1311140465, 1311140394, 1311140366, 1311140008, 1311140115 1311140014, 1311140371, 1311140238, 1311140306, 1311140332, 1311140404 1311140054, 1311140188, 1311140324, 1311140453, 1311140408, 1311140237 1311140220, 1311140372, 1311140325, 1311140088, 1311140535, 1311140355.

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

da Vinci Xi Surgical System, IS4000; || Assy, Distal SUJ, Inner, IS4000 || Material number: 380662-20 and 380662-21. || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, || endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical || procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

Material number: 380647-20; Serial numbers: 1311140430, 1311140586, 1311140058, 1311140392. 1311140277, 1311140307, 1311140094, 1311140100, 1311140569, 1311140102, 1311140421, 1311140092, 1311140009, 1311140070, 1311140267, 1311140333, 1311140492, 1311140391, 1311140057, 1311140294, 1311140508, 1311140565, 1311140105, 1311140122, 1311140469, 1311140521, 1311140378, 1311140456, 1311140230 1311140573, 1311140065, 1311140164, 1311140194, 1311140511, 1311140291, 1311140304, 1311140212, 1311140222, 1311140001, 1311140137, 1311140344, 1311140381, 1311140341, 1311140538, 1311140168, 1311140523, 1311140274, 1311140033, 1311140091 1311140248, 1311140141, 1311140436, 1311140418, 1311140548 1311140320, 1311140170, 1311140346. Material number 380746-22: Serial numbers: 1311140486 1311140539, 1311140174, 1311140183, 1311140327, 1311140347 1311140482, 1311140145, 1311140066, 1311140302, 1311140477 1311140084, 1311140211, 1311140103, 1311140083, 1311140050, 1311140488, 1311140365, 1311140207, 1311140459, 1311140557,  1311140423, 1311140045, 1311140440, 1311140231.

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

da Vinci Xi Surgical System, IS4000; || ASSY,USM,IS4000, || Material number: 380647-20 and 380647-22 || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, || endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

All lots

General and Plastic Surgery Devices

1

No

Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.

Serial Numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, SK1190

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan

da Vinci Xi Surgical System || Product Usage: || The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.

Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

General and Plastic Surgery Devices

2

No

US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

8MM, TIP-UP FENESTRATED GRASPER; || Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.