Events

Rappel de Device Recall ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters

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 Ethicon Endo-Surgery 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
    56940
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0361-2011
  • Date de mise en oeuvre de l'événement
    2009-01-13
  • Date de publication de l'événement
    2010-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95016
  • 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
    Staple, implantable - Product Code GDW
  • Cause
    The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. if the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. this may lead to an increase in procedure time, tissue manipulation, and a change in t.
  • Action
    Ethicon Endo-Surgery issued "Urgent Device Recall Event 1952" notification letters dated January 21, 2009 to their customers. They instructed their custormers to immediately discontinue use of the product. They are to complete and fax back the Business Reply Form. Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle. Replacement product should be received within 30-60 days after return. Customers can contact Stericycle concerning this recall at 1-866-861-6921, reference Event 1952.

Device

Device Recall ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters
  • Modèle / numéro de série
    Lot #'s: E4MD1T, E4MD5W, E4MD3Y, E4ME7J, E4MD4Z, E4ME7U, E4MD50 & E4MF0A
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA only, in the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Description du dispositif
    ENDOPATH¿ ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA