Events

Alerte De Sécurité sur EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement Button

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-09-17
  • Date de publication de l'événement
    2015-09-17
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150917.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: boston scientific endovive one step button, endovive button decompression tube and endovive low profile replacement button medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its endovive one step button, endovive button decompression tube and endovive low profile replacement button. endovive one step button: material number m00563020 (lot 1814947); moo563080 (lot 18179867 & 18212410); m00568510 (lot 18296155) endovive button decompression tube: material number m00580471 (lot 18262588) endovive low profile replacement button: m00568330 (lot 18210123, 18231256, 18249784, 18276188 & 18310069) the manufacturer has become aware that specific lots of the affected products may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the percutaneous endoscopic gastrostomy (peg) button. a user attempting to insert the decompression tube adapter will feel increased resistance when the protrusion contacts the button, and the user may then decide to pull out the decompression tube adapter, leading to delay of decompression. if the user applies additional force to fully insert the decompression tube adapter, it could dislodge the button into the stomach. if the decompression tube adapter is successfully inserted, then the increased resistance during removal could lead to pulling the entire endovive button out of the body, which would require surgical re-insertion. there is a remote possibility that manipulating the decompression tube adapter with the protrusion could lead to a tear or perforation of the button tube, which would allow for exposure to the peritoneal cavity which could then lead to infection (peritonitis). users are advised to immediately discontinue use of and segregate recalled product. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2015.

Device

EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement Button
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH