Events

Alerte De Sécurité sur Surgical table

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Mediland Enterprise Corporation. Linkou Factory. || Steris Corporation.

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
  • ID de l'événement
    I1606-237
  • Numéro de l'événement
    2014DM-0012037
  • Date
    2016-06-03
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has detected that there is a possibility that the pivot pin assembly on the surface of the table may become loose when the table is articulated, which could lead to the occurrence of potentially adverse events on patients or users.

Device

Surgical table
  • Modèle / numéro de série
    OT1000, OT1100 and OT1200, specific serials.
  • Description du dispositif
    The surgical table and table for surgery, are operating tables electrohydraulic, designed to carry out virtually all types of surgical procedures in cardiology, vascular surgery, cardiovascular, endoscopy, gynecology, urology, endurology, nephrectomy, neurology, neurosurgery, ophthalmology, orthopedics , abdominal, cystoscopy, thoracic and kidney, gallbladder, decay replacement, pacemaker insertions, HICKMAN catheters, BROVIAC insertions, shunts, VCI filters, cholangiographies, lung biopsies, implant defibrillation, NISSEN fundoplication; orthopedic reconstructive and hip repair procedures and lower extremities: total anterior hip proximal arthroplasty (AATHA); hip fracture; Tibial fracture; pelvic and acetabular fracture; fracture of the femur, thoracic and lumbar spine; arthroscopy and coating, implantation of nails in the hip, nailing of ENDER, intramedullary nails for femur, surgery of the tibia and elperoné. With the complement of the accessories of the table STERIS or MEDILAND. They allow the positioning and flexible articulation of the patient subjected to a surgical operation, designed specifically to offer the total flexibility of positioning of the patient that is required in modern surgical centers. They provide flexible and easy-to-use articulation mechanisms for patient positioning in reconstructive and restorative orthopedic procedures.
  • Manufacturer
    Mediland Enterprise Corporation. Linkou Factory. || Steris Corporation

Manufacturer

Mediland Enterprise Corporation. Linkou Factory. || Steris Corporation
  • Source
    NIDFSINVIMA