Events

Rappel de Cooper Surgical Advincula Arch

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 Cooper Surgical, Inc..

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
    63681
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0440-2013
  • Date de mise en oeuvre de l'événement
    2012-10-31
  • Date de publication de l'événement
    2012-11-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114523
  • 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
    Cannula, manipulator/injector, uterine - Product Code LKF
  • Cause
    Excessive pressure exerted on the uterine tip when attached to the arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle.
  • Action
    CooperSurgical issued notification on October 31, 2012, to all affected customers Fed X . The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return units for replacement. Customers with questions should contact Customer Serivce at 1-203-601-9818 or 800-243-2974. Customers were asked to fill out the attached Replacement of Recalled Product Form and fax it to 1-800-262-0105. For questions regarding this recall call 203-601-9818.

Device

Cooper Surgical Advincula Arch
  • Modèle / numéro de série
    Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.
  • Description du dispositif
    Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle || Ref: UMH750 || The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
  • Manufacturer
    Cooper Surgical, Inc.

Manufacturer

Cooper Surgical, Inc.
  • Adresse du fabricant
    Cooper Surgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Société-mère du fabricant (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA