Rappel de Device Recall Endopath Xcel with Optiview Technology

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
    79801
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1887-2018
  • Date de mise en oeuvre de l'événement
    2018-03-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Cause
    Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. in addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
  • Action
    The firm notified customers and distributors by letter on March 26, 2018, and March 27, 2018, respectively. Customers were informed of the issue and potential risk of prolonged surgery or introduction of minute particles. Customers were instructed to: 1. Examine your inventory immediately to determine if you have any products subject to this recall on hand and quarantine such product(s). 2. Remove the products subject to this recall from your inventory and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or Ethicon3546@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lot subject to this recall. 4. Customers are required to return all unused devices subject to this recall that are in their inventory immediately. 5. To return unused devices subject to this recall photocopy the completed BRF, place it in the box with the subject product(s), and affix the pre-paid authorized shipping label included with this recall notification letter. Distributors were instructed to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall on hand and quarantine such product(s). 2. Remove the product lot subject to this recall and communicate the issue to all relevant materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or Ethicon3546@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lot subject to this rec

Device

  • Modèle / numéro de série
    Lots P4TD1E R4001U R4052P
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
  • Description du dispositif
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
  • Manufacturer

Manufacturer

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