Device Recall da Vinci Xi EndoWrist Suction Irrigator

  • Modèle / numéro de série
    All
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
  • Description du dispositif
    da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; || PN 480299-03; and || SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. || General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Société-mère du fabricant (2017)
  • Source
    USFDA