Events

Rappel de Device Recall Altrus Energy Source

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 ConMed Electrosurgery.

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
    61814
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1678-2012
  • Date de mise en oeuvre de l'événement
    2012-05-07
  • Date de publication de l'événement
    2012-05-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109155
  • 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
    An investigation of the conmed electrosurgery altrus energy source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
  • Action
    ConMed Electrosurgery sent an "URGENT: MEDICAL DEVICE" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to complete and return a Business Reply Form to the firm via fax to 303-699-9854.

Device

Device Recall Altrus Energy Source
  • Modèle / numéro de série
    11AGZ003, 10KGZ001, 10MGZ001, 10MGZ003, 10MGZ004, 11AGZ001, 11AGZ002, 11AGZ003, 11AGZ004, 11AGZ006, 11AGZ007, 11BGZ001, 11BGZ002, 11BGZ003, 11DGZ001, 11DGZ002, 11DGZ003, 11DGZ004, 11DGZ005, 11DGZ006, 11DGZ007, 11DGZ008, 11DGZ009, 11DGZ010, 11DGZ011, 11DGZ012, 11DGZ013, 11DGZ014, 11DGZ015, 11DGZ016, 11DGZ017, 11DGZ018, 11FGZ001, 11FGZ002, 11FGZ003, 11FGZ005, 11FGZ006, 11FGZ007, 11FGZ008, 11GGZ001, 11GGZ002, 11GGZ003, 11GGZ004, 11GGZ006, 11GGZ007, 11GGZ008, 11GGZ009, 11HGZ001, 11HGZ002, 11HGZ003, 11HGZ005, 11HGZ007, 11HGZ008, 11HGZ009, 11HGZ010, 11HGZ011, 11HGZ012, 11HGZ013, 11HGZ014, 11HGZ015, 11HGZ016, 11HGZ017, 11HGZ018, 11HGZ019, 11HGZ020, 11HGZ021, 11HGZ022, 11HGZ023, 11HGZ024, 11HGZ025, 11HGZ026, 11HGZ027, 11JGZ001, 11JGZ002, 11JGZ003, 11JGZ004, 11KGZ001, 11KGZ002, 11KGZ003, 11KGZ004, 11KGZ005, 11KGZ006, 11KGZ007, 11KGZ008, 11KGZ009, 11KGZ010, 11KGZ011, 11KGZ012, 11KGZ013, 11KGZ014, 11KGZ015, 11LGZ002, 11LGZ003, 11LGZ004, 11LGZ005, 11LGZ006, 11LGZ007, 11LGZ008, 11LGZ009, 11LGZ010, 11LGZ011, 11LGZ012, 11LGZ013, 11LGZ014, 11LGZ015, 11LGZ016, 11LGZ017, 11LGZ018, 11MGZ001, 11MGZ002, 11MGZ003, 12AGZ001, 12AGZ003, 12AGZ004, 12AGZ005, 12AGZ006, 12AGZ007, 12AGZ008, 12AGZ009, 12AGZ010, 12AGZ011, 12AGZ012, 12AGZ013, 12AGZ014, 12AGZ015, 12AGZ016, 12BGZ001, 12BGZ002, 12BGZ003, 12BGZ004, 12BGZ005, 12BGZ006, 12BGZ008, 12BGZ009, 12CGZ001, 12CGZ002, 12CGZ003, 12CGZ004, 12CGZ005, 12CGZ006, 12CGZ008, 12CGZ009, 12CGZ010, 12CGZ011, 11GGZ005, 11HGZ004, 11HGZ006.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution and the country of Canada.
  • Description du dispositif
    Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany. || The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • Adresse du fabricant
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA