Device Recall PROcise XP Wand with Integrated Cable

  • Modèle / numéro de série
    Lot Numbers: 1092290, 1092291, 1092292
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    PROcise XP Wand with Integrated Cable REF EICA8872-01 || Product Usage: || PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    ArthroCare Medical Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • Société-mère du fabricant (2017)
  • Source
    USFDA