Events

Rappel de Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators

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 Gyrus Acmi, Incorporated.

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
    79762
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1952-2018
  • Date de mise en oeuvre de l'événement
    2018-04-17
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163258
  • 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
    Electrode, electrosurgical, active, urological - Product Code FAS
  • Cause
    There is a potential for the cord to spark and cause a fire.
  • Action
    Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on the enclosed Reply Form that you have received this information. Fax the completed Reply Form to 484-896-7128 regardless of whether you have any affected inventory at your facility. In addition, if you may have further distributed this product, please identify your customers, inform them at once of this action, provide the revised IFU and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this letter. For further questions, please call (508) 804-2600.

Device

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators
  • Modèle / numéro de série
    All lots manufactured before December 7, 2017  UDI (00821925008700)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.
  • Description du dispositif
    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) || The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Adresse du fabricant
    Gyrus Acmi, Incorporated, 136 Turnpike Rd, Southborough MA 01772-2118
  • Source
    USFDA