Device Recall da Vinci Xi Surgical System

  • Model / Serial
    Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
  • Product Description
    8MM, TIP-UP FENESTRATED GRASPER; || Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424,  1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    da Vinci Xi Surgical System, IS4000; || ASSY,DISTAL SUJ,OUTER,IS4000, || Material number: 380663-20 and 380663-21. || 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.
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Serial Numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, SK1190
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan
  • Product Description
    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.
  • Manufacturer