Events

Rappel de Device Recall Applied Medical Kii Optical Access System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Applied Medical Resources Corp.

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
    59560
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3069-2011
  • Date de mise en oeuvre de l'événement
    2009-12-18
  • Date de publication de l'événement
    2011-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103070
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Cause
    The recall was expanded on december 22, 2009 to include four models: c0r36, c0r37, c0r38, and c0r39. initially, applied medical conducted a voluntary recall on june 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm kii non-threaded optical access system, model c0r36, due to a potential weakness in the cannula tip, possibly resulting in a tip breakage.
  • Action
    Applied Medical Resources Corp. notified customers via an overnight "URGENT: MEDICAL DEVICE RECALL" letter dated December 22, 2009. The letter informed customers of the recalled products, problem, and actions to be taken. The letter asked that the listed recalled products be returned immediately. The customers were asked to check their inventory, complete the attached Voluntary Recall Notification Confirmation Form and fax as per the instructions. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).

Device

Device Recall Applied Medical Kii Optical Access System
  • Modèle / numéro de série
    1084821, 1084822, 1084823, 1089653, 1090833, 1096177
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.
  • Description du dispositif
    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 || Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Adresse du fabricant
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Société-mère du fabricant (2017)
    Applied Medical Corporation
  • Source
    USFDA