Events

Rappel de Device Recall Ureteroreno videoscope URFV2 and URFV2R

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 Olympus Corporation of the Americas.

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
    75993
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1252-2017
  • Date de mise en oeuvre de l'événement
    2016-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151898
  • 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
    Endoscope, accessories, narrow band spectrum - Product Code NWB
  • Cause
    Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
  • Action
    The firm, Olympus, sent an "Urgent Medical Device Safety Notice" on December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus were taking to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions and complete and return the OLYMPUS URGENT MEDICAL DEVICE SAFETY NOTIFICATION via fax to: Olympus Regulatory Affairs Department at 484-896-7128.

Device

Device Recall Ureteroreno videoscope URFV2 and URFV2R
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution-US Nationwide and country of: Canada.
  • Description du dispositif
    Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories || The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Adresse du fabricant
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA