Events

Rappel de Device Recall Fiber stripper

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 American Medical Systems Innovation Center - Silicon Valley.

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
    71534
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2178-2015
  • Date de mise en oeuvre de l'événement
    2015-05-28
  • Date de publication de l'événement
    2015-07-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138160
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Cause
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Action
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.

Device

Device Recall Fiber stripper
  • Modèle / numéro de série
    Model 80-1 0005-001; All product manufactured from April 8, 2012 to April 8, 2015
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
  • Description du dispositif
    Tool, Stripper W/BLD, 18S, Nonautoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
    American Medical Systems Innovation Center - Silicon Valley

Manufacturer

American Medical Systems Innovation Center - Silicon Valley
  • Adresse du fabricant
    American Medical Systems Innovation Center - Silicon Valley, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA