Device Recall EndoWrist

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, || Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    PN 410322-05Serial numbers: M10140807 M10140926 M10141028 M10141119 M11140917 M11141119 M10140812 M10141001 M10141029 M10141125 M11140922 M11141125 M10140814 M10141004 M10141031 M10141126 M11140926 M11141126 M10140818 M10141006 M10141104 M10141128 M11141001 M11141201 M10140826 M10141009 M10141105 M10141201 M11141004 M10140828 M10141015 M10141107 M11140808 M11141006 M10140902 M10141020 M10141111 M11140818 M11141009 M10140905 M10141022 M10141113 M11140826 M11141015 M10140917 M10141023 M10141114 M11140828 M11141020 M10140922 M10141024 M10141117 M11140904 M11141024
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 || The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the || instrument. || PN 410322-05
  • Manufacturer
  • Model / Serial
    PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. || The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
  • Manufacturer
  • Model / Serial
    da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101 SK0326 SK0654 SK0106 SK0358 SK0665 SK0119 SK0360 SK0701 SK0143 SK0382 SK0702 SK0144 SK0408 SK0710 SK0146 SK0438 SK0722 SK0171 SK0456 SK0728 SK0173 SK0484 SK0181 SK0492 SK0216 SK0496 SK0230 SK0516 SK0233 SK0548 SK0237 SK0552 SK0238 SK0610 SK0263 SK0612 SK0286 SK0631 SK0291 SK0649.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.
  • Product Description
    EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. || General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic 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 laparoscopic surgical || procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
  • Manufacturer
  • Model / Serial
    Part number 550675
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.
  • Product Description
    Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. || Intuitive Surgical Endoscopic Instrument Control System.
  • Manufacturer
  • Model / Serial
    Model number 410298-05 and 410298-06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to Florida and South Carolina
  • Product Description
    EndoWrist Stapler System User Manual Addendum and Wall Chart; || The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
  • Manufacturer