Events

Rappel de Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par ArthroCare Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71468
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2105-2015
  • Date de mise en oeuvre de l'événement
    2015-06-02
  • Date de publication de l'événement
    2015-07-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137892
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (hipot) specifications.
  • Action
    Smith&Nephew; sent an Urgent Notification letter dated June 10, 2015 via mail/courier service with delivery tracking/confirmation to affected customers. A response form is included in the notification letter. A follow up letter will be sent to non-responding consignees. Customers were instructed to complete the acknowledgement form and return via fax or email.

Device

Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable
  • Modèle / numéro de série
    Lot numbers 1093290 and 1091254
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
  • Description du dispositif
    EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable || 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 be 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
    ArthroCare Corporation

Manufacturer

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