Events

Rappel de Medtronic Octopus Nuvo Tissue Stabilizer

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 Medtronic Perfusion Systems.

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
    56902
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0134-2011
  • Date de mise en oeuvre de l'événement
    2010-09-13
  • Date de publication de l'événement
    2010-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94892
  • 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
    Instruments, surgical, cardiovascular - Product Code DWS
  • Cause
    Medtronic has received reports regarding the octopus nuvo tissue stabilizer stating that during use, the collet (a component of the device that stabilizes the head link) fractured, thereby causing immediate separation of the head link from the shaft of the device. the resulting potential hazards are that fragments of the collet could fall into the patient's chest cavity and/or damage the heart ti.
  • Action
    Medtronic sent an "Urgent Medical Device Recall Notice" dated September 14, 2010, to Risk Managers at each affected account. The letter described the issue, identified affected lot numbers, asked for immediate discontinued use of the device, quarantine all unused devices and to return unused devices to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428 and requested a recall certificate be faxed back to Medtronic indicated acknowledgement of the Recall Notice and quantity to be returned. If you need additional information, please contact Medtronic Cardiovascular Lifeline Technical Services at 877-526-7890, or your local Medtronic sales representative.

Device

Medtronic Octopus Nuvo Tissue Stabilizer
  • Modèle / numéro de série
    Lot #: 201002P030, 2010030795, 2010032195, 2010032196, 2010032690, 2010033377, 2010040102, 2010040103, 2010040673, 2010041001, 2010041500, 2010061786, 2010062722, 2010071111, 2010081105, 2010081987.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    within the US to: AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and Washington D.C. OUS to include: Belgium, Canada, Germany, Italy, Poland, Switzerland, United Kingdom.
  • Description du dispositif
    Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible articulating arm. The device is assembled within the thoracic cavity. Sterilized using ethylene oxide, non pyrogenic, disposable, single use only. || The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery procedures under direct visualization through a thoracotomy.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Adresse du fabricant
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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