Events

Rappel de Device Recall Covidien Emprint Ablation System

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 Covidien Medical Products (Shanghai) Manufacturing L.L.C..

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
    73438
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1187-2016
  • Date de mise en oeuvre de l'événement
    2016-02-23
  • Date de publication de l'événement
    2016-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144214
  • 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
    System, ablation, microwave and accessories - Product Code NEY
  • Cause
    Medtronic is voluntarily recalling specific item codes and production lots of covidien emprint" percutaneous antenna with thermosphere" technology due to the potential for the generator to shut down in the precence of high temperature measurements in the emprint" percutaneous antenna.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter dated February 23, 2016 to all affected customers via Federal Express or Certified Mail. The letter identified the affected product, problem and actions. Customers were advised to quarantine and discontinue use of the affected product and to Return product. For questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.

Device

Device Recall Covidien Emprint Ablation System
  • Modèle / numéro de série
    Model Numbers: CA15L1, CA20L1 and CA30L1
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide, VA/govt/military consignees.
  • Description du dispositif
    Short Percutaneous Antenna with Thermosphere" Technology || Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. || Long Percutaneous Antenna with Thermosphere" Technology || Product Usage: || The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
  • Manufacturer
    Covidien Medical Products (Shanghai) Manufacturing L.L.C.

Manufacturer

Covidien Medical Products (Shanghai) Manufacturing L.L.C.
  • Adresse du fabricant
    Covidien Medical Products (Shanghai) Manufacturing L.L.C., Building 10 789 Puxinglu, Pujiang, Minhang, Shanghaishi China
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA