Events

Rappel de LINA GOLD LOOP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SUPERIOR MEDICAL LIMITED.

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
    82881
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-09-02
  • 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 in december of 2009 lina medical issued an update to their "instructions for use" (ifu) to inform users that the loops should not be pre-tested on patients nor be used if de-shaped from their original rhomboid form. doing so can cause the loop to weaken break or cease functioning and can prolong the surgery of the patient.

Device

LINA GOLD LOOP
  • Modèle / numéro de série
    Model Catalog: EL-200-8 (Lot serial: 00-H557000); Model Catalog: EL-200-4 (Lot serial: 00-H557000); Model Catalog: EL-160-8 (Lot serial: 00-H557000); Model Catalog: EL-200-8 (Lot serial: 00-O932300); Model Catalog: EL-200-4 (Lot serial: 00-O932300); Model Catalog: EL-160-8 (Lot serial: 00-O932300); Model Catalog: EL-200-8 (Lot serial: 00-C908986); Model Catalog: EL-200-4 (Lot serial: 00-C908986); Model Catalog: EL-160-8 (Lot serial: 00-C908986); Model Catalog: EL-200-8 (Lot serial: 00-V131400); Model Catalog: EL-200-4 (Lot serial: 00-V131400); Model Catalog: EL-200-8 (Lot serial: 00-S123960); Model Catalog: EL-200-4 (Lot serial: 00-S123960); Model Catalog: EL-160-8 (Lot serial: 00-S123960); Model Catalog: EL-160-8 (Lot serial: 00-V131400); Model Catalog: EL-200-8 (Lot serial: 00-B142800); Model Catalog: EL-200-4 (Lot serial: 00-B142800); Model Catalog: EL-160-8 (Lot serial: 00-B142800); Model Catalog: EL-200-8 (Lot serial: 00-C167200); Model Catalog: EL-200-4 (Lot serial: 00-C167200); Model Catalog: EL-160-8
  • Description du dispositif
    LINA LOOP ENDOSCOPIC MONOPOLAR LOOP
  • Manufacturer
    SUPERIOR MEDICAL LIMITED

Manufacturer

SUPERIOR MEDICAL LIMITED