Events

Rappel de Device Recall Voyant Open Fusion Device

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 Applied Medical Resources Corp.

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
    71956
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2769-2015
  • Date de mise en oeuvre de l'événement
    2015-07-31
  • Date de publication de l'événement
    2015-09-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139445
  • 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
    Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
  • Action
    The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: - check inventory for recalled product - complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if facility is returning or has already used any of the products - Return the confirmation form(s) to Applied Medical by emailing to recall60669166@appliedmedical.com or faxing to (949) 713-8936. - Return affected product and a copy of the confirmation form(s) to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by e-mail at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by e-mail at lcontursi@appliedmedical.com.

Device

Device Recall Voyant Open Fusion Device
  • Modèle / numéro de série
    Model Number: EB040  Lot Numbers: 1243964, 1243975, 1244125  Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
  • Description du dispositif
    Voyant Open Fusion Device || Models: EB040 and EB040+ || Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Adresse du fabricant
    Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
  • Société-mère du fabricant (2017)
    Applied Medical Corporation
  • Source
    USFDA