Events

Rappel de Device Recall Precision Bipolar Device ClearGlide EVH

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 Datascope Corporation.

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
    38005
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1157-2007
  • Date de mise en oeuvre de l'événement
    2007-05-07
  • Date de publication de l'événement
    2007-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52710
  • 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
    endoscopic vessel harvesting system - Product Code GEI
  • Cause
    Datascope has experienced a higher than usual number of reports involving the precision bipolar device. reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
  • Action
    Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.

Device

Device Recall Precision Bipolar Device ClearGlide EVH
  • Modèle / numéro de série
    Part Number KTV 17 Lot numbers: 12492, Exp. 4/30/09; 12502, Exp. 4/27/09; 12512, Exp. 5/6/09.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Belgium, the Netherlands, and Germany.
  • Description du dispositif
    The ClearGlide EVH small with Scissors. || The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. || Datascope Cardiac Assist || Sterile || Manufactured for: || Datascope Cardiac Assist || 15 Law Drive || Fairfield, NJ 07004
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Adresse du fabricant
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA