Events

Alerta De Seguridad para Valleylab Laparoscopic Handset (four-function) with product code E2750

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por Medtronic Philippines Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    2017-084
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/413421-fda-advisory-no-2017-084
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2017-084 health warning on using covidien valleyab laparoscopic handset (four-function) with product code e2750 all are hereby advised by the food and drug administration (fda) about the lots of the following laparoscopic handsets with product code e2750 distributed by medtronic philippines inc. 32nd street bonifacio global city, fort bonifacio taguig city: product code description lot numbers e2750 valleylab laparoscopic handsets four-function 52990142x 53250061x 53610059x 60240065x 61220095x 52990144x 53250063x 53610061x 60520098x 61220098x 52990147x 53250065x 60240055x 60520104x 61300164x 52990151x 53610053x 60240059x 60870064x 61540145x 53250057x 53610055x 60240061x 61220093x 61540150x the cited product are being voluntarily recalled by medtronic philippines inc. because of the customer reports from its main manufacturer in other country on potential defect/malfunction of the device. in the report, the handset continues to operate upon release of the activation button. if it does not deactivate after release of activation button, it presents safety risk and possible health consequences like damage to the internal tissues. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-084.Pdf.

Device

Valleylab Laparoscopic Handset (four-function) with product code E2750

Manufacturer

Medtronic Philippines Inc
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    FDAP