Events

Rappel de ENDOPATH XCEL BLUNT TIP TROCAR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    72235
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-10-08
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    This recall has been initiated because ethicon endo-surgery is aware of an increase in reports of leaking in the endopath xcel with optiview technology trocars which can potentially lead to loss of pneumoperitoneum during a surgical procedure. pneumoperitoneum loss can have a range of potential consequences from customer annoyance to conversion from laparoscopic to open surgery.

Device

ENDOPATH XCEL BLUNT TIP TROCAR
  • Modèle / numéro de série
    Model Catalog: H12LP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D12LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D12XT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D11LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B11LPH (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B12LP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B11LP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B12LPH (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: K12LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: K11LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CB12LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CB11LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B12XT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B12SRT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B11LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B12LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B11LTH (Lot serial: >100 NUMBERS CON
  • Description du dispositif
    ENDOPATH XCEL BLUNT TIP TROCAR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.