Events

Rappel de Device Recall AEM Disposable Electrodes

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 Encision, Inc..

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
    61529
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1951-2012
  • Date de mise en oeuvre de l'événement
    2012-06-15
  • Date de publication de l'événement
    2012-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108356
  • 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
    Encision is performing a field correction to their aem disposable electrodes due to two consumer complaints reporting unanticipated alarms from the aem monitor while using the device. this issue could result delays or complications during surgical procedures.
  • Action
    Encision sent an Urgent Medical Device Recall letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to lubricate the contact on the instrument cord with a conductive gel (to be supplied by Encision) prior to making the connection of the cord to the instrument. Instructions for applying the gel were attached. This corrective action was temporary; allowing customers to use their inventory of devices and for new product in the short term, until a design correction can resolve the problem. Customers would be contacted by their Encision Sales Representative to review this information for their specific situation and train their staff on its correction. For questions customers should call 303-339-6917 or Customer Service at 800-998-0986. For questions regarding this recall call 303-339-6917.

Device

Device Recall AEM Disposable Electrodes
  • Modèle / numéro de série
    RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
  • Description du dispositif
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. || AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Adresse du fabricant
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Société-mère du fabricant (2017)
    Encision, Inc.
  • Source
    USFDA